Here is a simple solution to the pesky problem of finding what an acronym stands for in the Life Sciences (Medical Devices, Pharma, Biotech) and Food Industry. This app lists more than 3000 of them, curated from our database that contains over 10,000.
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Life Sciences (Medical Devices, Pharma, Biotech) and Food Industry Acronyms
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Abbreviation | Term |
---|---|
481 | FDA Form that must be filled out by an FDA Investigator to officially request collectoon of a sample at a site |
483 | Establishment Inspection Report issued on Form 483 |
21 CFR 111 | CGMP for Dietary Supplements |
21 CFR 210 | CGMP In Manufacturing, Processing, Packing, or Holding of Drugs; General |
21 CFR 211 | CGMP for Finished Pharmaceuticals |
21 CFR 212 | cGMP for Positron Emission Tomography Drugs |
21 CFR 820 | Medical Devices: Quality System Regulation |
510k | Premarket Submission to FDA |
513(g) | A written request to FDA seeking clarification on the classification of a device |
5S | Five S: Sort, Shine, Store, Standardize, Sustain |
7W | Seven Wastes |
AAA | Abdominal Aortic Aneurysm |
AADA | Abbreviated Antibiotic Drug Application |
AAM | Alpha Angle Measurement |
AAOS | American Academy of Orthopedic Surgeons |
AAP | Amino Acid Profile |
AAPI | American Association of Physicians of Indian Origin |
ABD | Army Battle Dressing |
ABF | Anti Biotic Free |
ABG | Arterial Blood Gas |
AC | Aerobic Count |
ACA | Anomalous Coronery Artery |
ACA | Affordable Care Act |
ACC | Amercian College of Cardiology |
ACCME | Accreditation Council for Continuing Medical Education |
ACE | Adverse Clinical Event |
ACL | Anterior Cruciate Ligament |
ACO | Accountable Care Organization |
ACRA | Associate Commissioner for Regulatory Affairs |
ACRA | Associate Commissioner for Regulatory Affairs (FDA) |
ACS | American College of Surgeons |
ACS | Acute Coronary Syndromes |
ADD | Attention Deficity Disorder |
ADE | Adverse Drug Event |
ADE/ADR | Adverse Drug Event or Reaction |
ADHD | Attention Deficit Hyperactivity Disorder |
ADI | Advanced Diagnostic Imaging |
ADL | Activity of Daily Living |
ADR | Adverse Drug Reaction |
ADRS | Adverse Drug Reporting System |
ADVAMED | Advanced Medical Technology Association |
AE | Above Elbow |
AE | Adverse Event |
AET | Antimicrobial Effectiveness Test (aka APE, PET) |
AFAP | As Far As Possible |
AFIB | Atrial Fibrillation |
AFM | Atomic Force Microscopy |
AFO | Ankle Foot Orthosis |
AHA | Amercian Heart Association |
AHLR | Actual Helium Leak Rate |
AHRQ | Agency for Healthcare Research and Quality |
AHU | Air Handling Unit (HVAC) |
AI | Active Ingredient |
AI | Artificial Intelligence |
AID | Auto Immune Disease |
AID | Anti Inflammatory Drug |
AIDC | Automatic Identification and Data Capture |
AIFA | Agenzia Italiano del farmaco - Italian Medicines Agency |
AIM | Active Ingredient Manufacturer |
AIMDD | Active Implantable Medical Device |
AKA | Above Knee Amputation |
aka | Also Known As |
ALARA | As Low As Reasonably Achievable |
ALARP | As Low As Reasonably Possible |
ALS | Amyotrophic Lateral Sclerosis |
ALT | Argon Laser Trabeculoplasty (for Glaucoma) |
AM | Additive Manufacturing |
AMD | Age-related Macular Degeneration |
AMI | Acute Myocardial Infarction |
AMI | American Meat Institute |
AMP | Adenosine Monophosphate |
AMPAC | Guidance on Post-approval Changes for Analytical Methods |
AMS | Agricultural Marketing Service |
ANA | American Nurses Association |
ANADA | Abbreviated New Animal Drug Application |
ANDA | Abbreviated New Drug Application |
ANDI | Analytical Data Interchange |
ANOM | Analysis of Means |
ANOVA | Analysis of Variance |
ANPR | Advance Notice of Public Rulemaking |
ANSI | American National Standards Institute |
ANVISA | Agencia Nacional De Vigilancia Sanitaria; Brazilian Health Regulatory Authority |
AO | Auditing Organization |
AOAC | Association of Analytical Communities (previously Assoc. of Anal. Chemistry) |
AOQ | Average Outgoing Quality |
AP | Anterior Posterior |
AP | Activated Protein |
AP | Acetaminophen |
AP | Assistant Professor |
AP | Advisory Panel |
AP | Acupuncture |
AP | Anatomy and Physiology |
AP | Authorized Person |
APA | Aseptic Processing Area |
APC | Aerobic Plate Count |
APE | Antimicrobial Preservative Effectiveness Test (a.k.a. AET, PET) |
APF | Animal Product Free |
API | Active Pharmaceutical Ingredient |
APLB (CBER) | Advertising and Promotional Labeling Branch (CBER) |
APQP | Advanced Product Quality Planning |
APR | Annual Product Review |
APSB (OC) | Accounting Policy and Systems Branch (OC) |
APTC | Advanced Premium Tax Credit |
APTF | Application Policy Task Force |
AQL | Acceptable Quality Level or Acceptance Quality Limit |
AQL | acceptable quality level |
AR | approvable letter |
ARAB (OC) | Accounting Reports and Analysis Branch (OC) |
ARC | American Red Cross |
ARCH | Administrative Resources Core Hub (CFSAN) |
ARCRT | American Registry of Clinical Radiography Technologists |
ARDB (CDRH) | Anesthesiology and Respiratory Devices Branch (CDRH) |
ARF | Acute Renal Failure |
ARIES | Administrative Resources Information Exchange System |
ARL (ORA) | Arkansas Regional Laboratory (ORA) |
ARM | Alliance for Regenerative Medicine |
ARNet | Acquisition Reform Network |
AROM | Active Range of Motion |
ARPA | Advanced Research Projects Agency (DoD) |
ARRT | American Registry of Radiologic Technologists |
ARS | Advancing Regulatory Science |
AS | Artificial Sweetner |
ASA | Acoustical Society of America |
ASA | American Society of Anesthesiologists |
ASA | American Statistical Association |
ASA | Americans for Safe Access |
ASB (OC) | Accounting Services Branch (OC) |
ASB (OC) | Administrative Services Branch (OC) |
ASBPO | Armed Services Blood Program Office |
ASC | Advertising Standards Council (Canada) |
ASCII | American Standard Code for Information Interchange (computer files) |
ASCO | American Society for Clinical Oncology |
ASCP | American Society for Clinical Pathology |
ASCPT | American Society for Clinical Pharmacology and Therapeutics |
ASD | Atrial Septal Defect |
ASEAN | Association of South Eastern Nations |
ASGE | American Society for Gastrointestinal Endoscopy |
ASICS | Application Specific Integrated Circuit(s) |
ASIS | Anterior Superior Iliac Spine |
ASL | Approved Supplier List |
ASM | American Society for Microbiology |
ASME | American Society of Mechanical Engineers |
ASMF | Active Substance (Drug) Master File |
ASP | Acceptance Sampling Plan |
ASPR | Assistant Secretary for Preparedness and Response (HHS) |
ASQ | American Society for Quality |
ASQC | American Society for Quality Control |
ASTHO | Association of State and Territorial Health Officials |
ASTM | American Society for Testing and Materials |
AT (OC) | Acquisitions Team (OC) |
ATC | Anatomical Therapeutic Chemical (Drug Classification System) (WHO) |
ATCC | American Type Culture Collection |
ATMP | Advanced Therapy Medicinal Product |
ATP | Adenosine Triphosphate |
ATS (CDER) | Applied Technologies Staff (CDER) |
AV | Actuarial Value |
AVG | Average |
AVL | Approved Vendor List |
AVN | Avascular Necrosis |
AVRMVR | Aortic Valve Repair or Mitral Valve Replace or Repair |
Aw | Water Activity |
AWC | adequate and well-controlled |
AWOL | absent without official leave |
AWP | average wholesale price |
AWS | alternate work schedule |
B&F (CVM) | Budget and Finance Team (CVM) |
B/F or BF | Bacteriostasis/Fungistasis (obsolete term for Method Suitability Test as part of the Sterility Test) |
B/F/S | Blow-Fill-Seal (see also BFS) |
BA | Bio Availability |
BA | Bio Assay |
BA | Barrel Aged |
BA/BE | Bioavailability/Bioequivalence |
BAC | billing agency code |
BaCON | Bacterial Contamination study |
BACPAC | Guidance on Scale-up and Post-approval Changes for Bulk Actives |
BACPAC | bulk activities postapproval changes |
BAER | Brief Adverse Event Report Review (CDRH) |
BAM | Bacterial Analytical Manual (FDA Publication) |
BARDA | Biomedical Advanced Research and Development Authority |
BARQA | British Association of Research Quality Assurance |
BARS (CDER) | Business Analysis and Reporting Staff (CDER) |
BB | Benzyl Benzoate |
BBB | Bad Bug Book |
BCB (CFSAN) | Bioanalytical Chemistry Branch (CFSAN) |
BCC | Basal Cell Cancer |
BCC | Biopharmaceutics Coordinating Committee (internal CDER/OPS committee) |
BCE | Beneficial Clinical Event |
BCP | Bureau of Consumer Protection (FTC) |
BCS | Biopharmaceutics Classification System |
BDB | Biologic Devices Branch (CBER) |
BDB (CDRH) | Bacteriology Devices Branch (CDRH) |
BDR | Background Diabetic Retinopathy |
BDSS | Biologics Decision Support System |
BDU | Brain Dead User (common IT explanation of computer problem) |
BE | Below Elbow |
BEA | Bureau of Economic Analysis (U.S. Department of Commerce) |
BECON | Bioengineering Consortium (NIH) |
BENS | Business Executives for National Security |
BEq | bioequivalence |
BER | Blood Establishment Registration and Product Listing (CBER) |
BEST | Biomonitoring of Environmental Status and Trends Program (U.S. Geological Survey) |
BET | Bacterial Endotoxin Test |
BFAC | Biologics Field Advisory Committee (CBER) |
BfArM | Bundesinstitut fur Arzneimittel und Medizinprodukte (German Ministry of Health) |
BFB | Biodegradable Food Bag |
BFL | Biologic establishment license number (ORA AofC code) |
BFS | Blow-Fill-Seal (see also B/F/S) |
BG | Best Guess |
BGA | Bundesgesundheitsamt (German Federal Health Office) |
BI | Biological Indicator |
BIAB | Brew In A Bag |
BIMO | bioresearch monitoring |
BIMS | Biologic IND Management System |
BIND | Biological Investigational New Drug |
BIO | Biotechnology Industry Organization |
BIO | Biotechnology Industry Association |
BIOB (CFSAN) | Biostatistics Branch (CFSAN) |
BIRA | The British Institute of Regulatory Affairs |
BIRAMS | Biologics Investigational and Related Applications Management System |
BIRS | Business Intelligence Reporting Solution |
BISTI | Biomedical Information Science and Technology Initiative (NIH) |
BISTIC | Biomedical Information Science and Technology Initiative Consortium (NIH) |
BK | Below Knee |
BKA | Below Knee Amputation |
BLA | Biologics License Application |
BLS | biologics license supplement |
BLST (CFSAN) | Building and Laboratory Services Team (CFSAN) |
BLT | Blood Logging and Tracking System (CBER) |
BMB (CFSAN) | Bioanalytical Methods Branch (CFSAN) |
BMBL | Biosafety in Microbiological and Biomedical Laboratories (CDC Publication) |
BMBL | Biosafety in Microbiological and Biomedical Laboratories (CDC) |
BMD | Bone Mineral Density |
BMP | Bone Morphogenetic Protein |
BMP | Base Metabolic Panel |
BMR | Basal Metabolic Rate |
BMS | Bare Metal Stent |
BNA | Bureau of National Affairs |
BNF | biotechnology notification file |
BOCB (CFSAN) | Biological and Organic Chemistry Branch (CFSAN) |
BOCF | baseline observation carried forward |
BoK | Body of Knowledge |
BP | British Pharmacopoeia |
BP | Base Pair |
BPA | blanket purchase agreement |
BPA | Bureau of Pharmaceutical Assessment (Canada) |
BPAC | Blood Products Advisory Committee (CBER) |
BPB (CBER) | Blood and Plasma Branch (CBER) |
BPBM | Bovine Porous Bone Mineral |
BPC | Bulk Pharmaceutical Chemical |
BPC | Bureau of Policy and Coordination (Canada) |
BPD | Bronchopulmonary Dysplasia |
BPD | biological product deviation |
BPHTN | Blood Pessurehypertension |
BPL | biologic product license number (ORA AofC code) |
BPR | business process re-engineering |
BPSRG | Biomedical and Pharmaceutical Sciences Research Group (UK) |
BPWG | Business Process Working Group |
BRCC | Biologics Research Coordinating Committee (CBER) |
BRMD | Bureau of Radiation and Medical Devices (Canada) |
BrMIS | Bioresearch Monitoring Information System |
BRMS | Biologics Regulatory Management System |
BRVO | Branch Retinal Vein Occlusion |
BSB (CFSAN) | Biotechnology Studies Branch (Chicago, Illinois) (CFSAN) |
BSC | Biological Safety Cabinet |
BSC | Blood Safety Committee |
BSC | Business Service Centers |
BSE | Bovine Spongiform Encephalopathy (Mad Cow Disease) |
BSI | British Standards Institution |
BSL | Biological Safety Level or Bio Safety Level |
BSL | Biological Safety Level (pathogenicity risk) |
BTC | PQRI Biopharmaceutics Technical Committee |
BTCB (CBER) | Blood and Tissue Compliance Branch (CBER) |
BTD | Breakthrough Therapy Designation |
BTR | Blood and Tissue Registration System |
BUD | Beyond Use Dating (from USP <797> - Compounding Pharmacies) |
BVF | Bone Void Filler |
BX | Biopsy |
C Chart | An SPC Chart based on Counts of Defects |
C of A | certificate of analysis |
C of A or CoA | Certificate of Analysis (also CoA) |
C3I | communications, command, control, and intelligence |
CA | Corrective Action |
CA | Conditional Approval |
CAB | conformity assessment body |
CAB (OC) | Computer Applications Branch (OC) |
CABE | corrective action(s) being effected |
CABG | Coronary Artery Bypass Graft |
CABG | Coronary Artery Bypass Graft Surgery |
CAC | Certified Application Counselor |
CAC/Codex | Codex Alimentarius Commission |
CACBERS | Committee for the Advancement of CBER Science |
CACTIS | Center ADP/TC Computer Tracking and Inventory System (CFSAN) |
CAD | control of automated processes |
CALA | computer-assisted license application |
CAMD | Competent Authority Medical Devices |
CAMP | Comprehensive Antimicrobial Management Program |
CAN | common accounting number |
CANDA | computer assisted new drug application |
CANDA/CAPLA | Computer-assisted New Drug Application/Product License Application |
CAO | change of appointing office |
CAP | College of American Pathologists |
CAP | Consumer Assistance Program |
CAPA | Corrective Action and Preventive Action |
CAPA | Corrective and Preventative Action |
CAPLAR | Computer-Assisted Product License Application Review |
CAR | Corrective Action Request |
CARS | Compliance Achievement Reporting System |
CAs | Competent Authorities |
CAS | Chemical Abstract Service |
CASE | computer aided software engineering |
CASPER | Center Automated System Process Exchange and Reporting (CFSAN) |
CAT | Computed Axial Tomography |
CBA | Certified Biomedical Auditor |
CBA | Columbia Blood Agar |
CBC | Complete Blood Count |
CBE | Changes Being Effected |
CBE 30 | CBE with 30 days notice to FDA |
CBER | Center for Biologics Evaluation and Research |
CBER | Center for Biologics Evaluation and Research (FDA) |
CBIAC | Chemical and Biological Defense Information Analysis Center (DoD) |
CBO | Congressional Budget Office (U.S.) |
CBP | Customs and Border Protection (U.S. Department of Homeland Security) |
CBRA | California Biomedical Research Association |
CBRG | Cancer Biomarkers Research Group (NCI) |
CBRN | Chemical Biological Radiological Nuclear |
CBT | Computer-Based Training |
CC | Chief Complaint |
CC | Conference Call |
CC | Coordinating Committee |
CCAPA | Correction, Corrective Action and Preventive Action |
CCB | Change Control Board |
CCB | Chemical Contaminants Branch (CFSAN) |
CCC | Compliance Coordinating Committee (CDER) |
C-CEList | Cleanrooms and Controlled Environments Email Discussion Group |
CCHIT | Certification Commission for Healthcare Information Technology |
CCI | Corrected Count Increment |
CCIIO | Center for Consumer Information and Insurance Oversight |
CCP | Critical Control Point |
CCR | CDER request for collaborative review |
CCR | Center for Cancer Research (NCI) |
CCRA | Clinical Contract Research Association (UK) |
CCRC | certified clinical research coordinator |
CCST (CFSAN) | Clinical Chemistry Support Team (CFSAN) |
CCT | Certified Calibration Technician |
CD | Chlorine Dioxide |
CDASH | Clinical Data Acquisition Standards Harmonization |
CDC | Centers for Disease Control and Prevention |
CDC | Center for Disease Control |
CDC | Centers for Disease Control and Prevention |
CDC | Centers for Disease Control and Prevention (USA) |
CDDI | Collaboration on Drug Development Improvement (or Initiative) |
CDDTB | Career Development and Directed Training Branch (CBER) |
CDER | Center for Drug Evaluation and Research |
CDH | Congenital Dislocation of Hip |
CDHS | California Department of Health Services |
CDIS | Component Distribution Information System |
CDMO | Contract Development and Manufacturing Organization |
CDRH | Center for Devices and Radiological Health |
CDRH | Center for Devices and Radiological Health (FDA) |
CDRS (CFSAN) | Case Development and Recall Staff (CFSAN) |
CDTL | Cross Discipline Team Leader |
CDUS | Clinical Data Update System (NCI) |
CE | European Conformity or Conformité Européenne |
CE | Concurrent Engineering |
CE | Cause and Effect |
CE | Continuing Education |
CE | Capillary zone Electrophoresis |
CE Mark | CE (Conformite Europeene or European Conformity) marking |
CEA | Council of Economic Advisers |
CEARS | CBER Error and Accident Reporting System |
CEB | Clinical Evaluation Branch (CBER) |
CEB | Compliance and Enforcement Branch (CFSAN) |
CEFIC | European Chemical Industry Council |
CE-FO (ORA) | Central Regional Field Office |
CEMB (CDRH) | Cardiac Electrophysiology and Monitoring Devices Branch (CDRH) |
CEN | Comite Europeen De Normalisation (European Committee for Standardization) |
CEN | European Committee for Standardization |
CEN | Centre for European Norm |
CENELEC | Comité Européen de Normalisation Électrotechnique; English: European Committee for Electrotechnical Standardization |
CEO | Chief Executive Officer |
CERCLIS | Comprehensive Environmental Response, Compensation and Liability Information System (Epa) |
CERG | CBER Emergency Relocation Group |
CERSI | Centers of Excellence In Regulatory Science and Innovation |
CERT | Community Emergency Response Team |
CERTS | Centers for Education and Research on Therapeutics (DHHS) |
CES | Consumer Education Staff (CFSAN) |
CFAST | Coalition for Accelerating Standards and Therapies |
CFC | Central File Number (ORA) |
CFC | Combined Federal Campaign |
CFD | computational fluid dynamic |
CFDA | China FDA |
CFDA | Catalog of Federal Domestic Assistance |
CFG | Center for Functional Genomics (NCTR) |
CFG | Certificate for Foreign Government |
CFO | Chief Financial Officer |
CFR | Code of Federal Regulations USA |
CFR | Code of Federal Regulations |
CFSAN | Center for Food Safety and Nutrition |
CFSAN | Center for Food Safety and Applied Nutrition (Part Fda) |
CFSAN | Center for Food Safety and Applied Nutrition |
CFU | Colony Forming Unit |
CFW | Carbon Filter Water |
CG | Center of Gravity |
CGCS | computer-generated cover sheet |
CGI | common gateway interface |
cGLP | Current Good Lab Practices |
cGMP | Current Good Manufacturing Practice |
CGMPR | Current Good Manufacturing Practices Regulations |
CGS | Contract and Grants Staff (ORA) |
cGy | Centigray (Radiation) |
CHAT | Chemical Hazards Assessment Team (CFSAN) |
CHC | Community Health Center |
CHD | Congenital Hip Dysplasia |
CHID | Combined Health Information Database (NIH) |
CHIP | Children’s Health Insurance Program |
CHISSA | Center for High Integrity Software System Assurance |
CHMP | Committee for Medicinal Products for Human Use (EU) |
CHO cells | Chinese Hamster Ovary Cells |
CHPA | Consumer Healthcare Products Association |
CI | Controlled Items |
CI | Clinical Investigator |
CI | Continuous Improvement |
CI | Color Index |
CI/KR | Critical Infrastructure and Key Resources |
CIA | Corporate Integrity Agreement |
CIAO | Critical Infrastructure Assurance Office |
CIN | Color Index Number (ORA AofC Code) |
CIO | Chief Information Officer |
CIOMS | Council for International Organizations of Medical Sciences (WHO) |
CIP | Clean In Place |
CIP | Continuous Improvement Process |
CIP | Critical Infrastructure Protection |
CIPP | Critical Infrastructure Protection Program |
CIRMS | Council on Ionizing Radiation Measurements and Standards |
CIRS | Center Information Retrieval System (CDRH) |
CIS | Compliance Information Branch (CFSAN) |
CIS | Cancer Information Service (NCI) |
CIS | catastrophic incident supplement (FEMA) |
CISET | Committee on International Science, Engineering and Technology |
CIT | Center for Information Technology (NIH) |
CK | Coaching Kata |
CL | Center Line |
CL | Central Limit |
CLA | Center Line Average |
CLA | Conference Lodging Allowance |
CLCA | Closed Loop Corrective Action |
CLD | Chronic Lung Disease |
CLIA | Clinical Laboratory Improvement Ammendments |
CLIS | Clinical Laboratory Improvement Services |
CLO | Career Limiting Opportunity |
CLP | Clinical Laboratory Products |
CLSI | Clinical and Laboratory Standards Institute |
CLT | Central Limit Theorem |
CM | Chemistry and Manufacturing (Canada) |
CM | Committee Meeting |
CMA | Chemical Manufacturers Association |
CMA | Conditional Marketing Approval |
CMC | Chemistry, Manufacturing, and Control |
CMC | Carpo Meta Carpal |
CMC | Canadian Meat Council |
CMC | Chemistry and Manufacturing Controls section of applications |
CMCC | Chemistry and Manufacturing Controls Coordinating Committee (CDER) |
CMCCC | Chemistry and Manufacturing Controls Coordinating Committee (internal CDER/OPS committee) |
CMDCAS | Canadian Medical Devices Conformity Assessment System |
CMDR | Canadian Medical Device Regulations |
CMF | Craniomaxillofacial |
CMfgE | Certified Manufacturing Engineer |
CMI | Consumer Medical Information |
CMI | Certified Mechanical Inspector |
CMM | Capability Maturity Model |
CMM | Coordinate Measuring Machine |
CMO | Contract Manufacturing Organization |
CMQ/OE | Certified Manager of Quality / Operational Excellence |
CMQ-OE | Certified Manager of Quality / Operational Excellence |
CMS | Centers for Medicare and Medicaid Services |
CMS | Centers for Medicare & Medicaid Services |
CNC | Computer Numerically Controlled |
CND | Can Not Duplicate, or Could Not Duplicate |
CO | Commissioned Officer |
CO | Compliance Officer |
CO | Contract Officer |
COA | Certificate of Analysis |
CoA | Certificate of Analysis (also C of A) |
COB | Coordination of Benefits |
COB (OC) | Contract Operations Branch (OC) |
COBRA | Consolidated Omnibus Budget Reconciliation Act |
COBRA | Consolidated Omnibus Budget Reconciliation Act |
COBTA | Council on Biologics and Therapeutic Agents (of AVMA) |
CoC | Certificate of Compliance |
COCB (CFSAN) | Communication and Coordination Branch (CFSAN) |
CoCr | Cobalt Chrome Alloy |
CODB (CDRH) | Cardiovascular and Ophthalmic Devices Branch (CDRH) |
CODEX | Codex Alimentarius |
CoE | Center of Excellence |
COE | certificate of exportability |
CofA | Certificate of Analysis |
CofC | Certificate of Compliance |
COI | Conflict of Interest |
COMIS | Center Office Management Information System |
COMIS | Center-wide Oracle Management Information System (COER) |
COMIS | Center-wide Oracle Management Information System |
COMSTAT | Compliance Status Information System |
COOL | Country-Of-Origin Labeling |
COOL | Country of Origin Labeling |
COOP | Continuity of Operations Plan |
CO-OP | Consumer Operated and Oriented Plan |
COPQ | Cost of Poor Quality |
COQ | Cost of Quality |
COS | Certificate of Suitability |
COSTART | Coding Symbols for Thesaurus of Adverse Reaction Terms |
COTS | Commercial Off The Shelf |
COTS | Commercial Off The Shelf software |
Cp | Process Capability Potential |
cp | Compliance Program |
cP | Centipoise |
CP | Cerebral Palsy |
CP | Control Plan |
CPAP | Continuous Positive Airway Pressure |
CPB | Compliance Programs Branch (CFSAN) |
CPC | Compliance Policy Council |
CPDF | Central Personnel Data File (OPM) |
CPG | Compliance Policy Guide |
CPG | Compliance Policy Guide (FDA) |
CPGM | Compliance Program Guidance Manual |
CPhT | Certified Pharmacy Technician |
CPI | Consumer Price Index |
CPI | Consumer Price Index |
Cpk | Process Capability Centered (aka Actual) |
CPL | Clinical Pathology Lab |
CPM | Continuous Passive Motion |
CPMP | Committee on Proprietary Medicinal Products (EU; obsolete – see CHMP and CVMP) |
CPP | Certificate of Pharmaceutical Product |
CPP | Critical Process Parameter |
CPP | Critical Process Parameters |
CPR | Cardio Pulmonary Resuscitation |
CPSC | Consumer Product Safety Commission |
CPT | Current Procedural Terminology |
CPT Code | Current Procedural Terminology Code |
CPV | Continued Process Verification |
CQA | Certified Quality Auditor |
CQA | Critical Quality Attributes |
CQE | Certified Quality Engineer |
CQI | Continuous Quality Improvement |
CQIA | Certified Quality Improvement Associate |
CQT | Certified Quality Technician |
CR | Collection Report |
CR | Clean Room |
CRA | Clinical Research Associate |
CRADA | Cooperative Research and Development Agreement |
CRAMS | Contract Research and Manufacturing Services |
CRB | Change Review Board |
CRB | CAPA Review Board |
CRB | Complaints Review Board |
CRE | Certified Reliability Engineer |
CRF | Case Report Form |
CRM | Corporate Records Management |
CRM | Customer Relationship Management |
CRM | Cardiac Rhythm Management |
CRN | Certified Radiology Nurse |
CRNA | Certified Registered Nurse Anesthist |
CRO | Clinical Research Organization |
CRO | Contract Research Organization |
CRR | Consult Review Request |
CRT | Cardiac Resynchronization Therapy |
CS | Clinically Significant |
CS (CVM) | Communications Staff (CVM) |
CSA | Canadian Standards Association |
CSB | Chemical Safety and Hazard Investigation Board |
CSB | Customer Support Branch (OC) |
CSC | Computational Science Center |
CSCP | Certified Supply Chain Professional |
CSE | Control Standard Endotoxin |
CSF | Critical Success Factor |
CSI | Consumer Safety Inspector |
CSO | Consumer Safety Officer |
CSO | Consumer Safety Officer (FDA) |
CSP | Compounded Sterile Preparation (from USP <797> - Compounding Pharmacies) |
CSPI | Center for Science In The Public Interest |
CSQA | Certified Software Quality Analyst |
CSQE | Certified Software Quality Engineer |
CSQP | Certified Supplier Quality Professional |
CSR | Customer Service Records |
CSR | Cost-Sharing Reduction |
CSREES | Cooperative State Research, Education and Extension Services (USDA) |
CSSBB | Certified Six Sigma Black Belt |
CSSGB | Certified Six Sigma Green Belt |
CST | Consumer Safety Technician |
CSV | Computer System Validation |
CSV | Comma Separated Value |
CT | Computed Tomography |
CT | Chemotherapy |
CTA | Clinical Trial Application |
CTC | Common Toxicity Criteria |
CTD | Common Technical Document |
CTFA | Cosmetics, Toiletries and Fragrance Association (obsolete name – see PCPC) |
CTO | Contract Testing Organization |
CTP | Center for Tobacco Products |
CTQ | Critical to Quality |
CTR | Carpal Tunnel Release |
CTRS | CDRH Time Reporting System |
CTS | Carpal Tunnel Syndrome |
CTS | Center Tracking System |
CTS | Correspondence Tracking System |
CV% | Coefficient of Variation |
CVA | Cerebrovascular Accident |
CVB | Center for Veterinary Biologics |
CVD | Cardiovascular Disease |
CVM | Center for Veterinary Medicine |
CVMP | Committee for Medicinal Products for Veterinary Use (EU) |
CVP | Central Venous Pressure |
CWA | Clean Water Act |
CXR | Chest X Ray |
CY | Calendar Year |
D | Detection |
D&D | Design and Development |
D/C | Discontinue |
DAA | Designated Approving Authority |
DAAP (CDER) | Division of Anesthesia and Analgesia Products (CDER) |
DAARP (CDER) | Division of Anesthesia, Analgesia, and Rheumatology Products (CDER) |
DAC (CFSAN) | Division of of Analytical Chemistry (CFSAN) |
DADS | Developers and Distributors System |
DAE | Division of Applied Engineering (OC) |
DAGID | Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (CDRH) |
DAIG | Data Analysis Integration Group (A Group At USDA) |
DailyMed | NLM-based database of information on marketed drugs including FDA-approved labels. |
DAIOP (CDER) | Division of Anti-infective and Ophthalmology Products (CDER) |
DAL | Defect Action Level |
DAPR (CDER) | Division of Applied Pharmacology Research (CDER) |
DAR (CVM) | Division of Animal Research (CVM) |
DARPA | Defense Advanced Research Projects Agency (DoD) |
DARRTS | Document Archiving, Reporting and Regulatory Tracking System |
DART | Developmental and Reproductive Toxicology |
DAS (CFSAN) | Division of Administrative Services Management (CFSAN) |
DAS (NCTR) | Division of Administrative Services (NCTR) |
DAT | diet as tolerated |
DATS | Document Accountability and Tracking System (CBER) |
DAWN | drug abuse warning network |
DB | double-blind |
DB (CBER) | Division of Biostatistics (CBER) |
DB (CDRH) | Division of Biology (CDRH) |
DB I (CDER) | Division of Biometrics I (CDER) |
DB II (CDER) | Division of Biometrics II (CDER) |
DB III (CDER) | Division of Biometrics III (CDER) |
DB IV (CDER) | Division of Biometrics IV (CDER) |
DB V (CDER) | Division of Biometrics V (CDER) |
DB VI (CDER) | Division of Biometrics VI (CDER) |
DBA | Doing Business As |
DBA (CBER) | Division of Blood Applications (CBER) |
DBC (CFSAN) | Division of Bioanalytical Chemistry (CFSAN) |
DBCP (CBER) | Division of Blood Collection and Processing (CBER) |
DBE (CDER) | Division of Bioequivalence (CDER) |
DBEC (OC) | Division of Budget Execution and Control (OC) |
DBEPA (CBER) | Division of Blood Establishment and Product Applications (CBER) |
DBGLPC (CDER) | Division of Bioequivalence and Good Laboratory Practices Compliance (CDER) |
DBGNR (CFSAN) | Division of Biotechnology and GRAS Notice Review (CFSAN) |
DBM (CDRH) | Division of Bioresearch Monitoring (CDRH) |
DBMS | Database Management System |
DBMSS (CDER) | Division of Business Management Services and Solutions (CDER) |
DBOP (CDER) | Division of Biologic Oncology Products (CDER) |
DBPAP (CBER) | Division of Bacterial, Parasitic and Allergenic Products (CBER) |
DBRA (NCTR) | Division of Biometry and Risk Assessment (NCTR) |
DBS (CDRH) | Division of Biostatistics (CDRH) |
DBT (NCTR) | Division of Biochemical Toxicology (NCTR) |
DC | Discontinue |
DC | discharge |
DC (CVM) | Division of Compliance (CVM) |
DC (NCTR) | Division of Chemistry (NCTR) |
DC I (CDER) | Division of Chemistry I (CDER) |
DC II (CDER) | Division of Chemistry II (CDER) |
DC III (CDER) | Division of Chemistry III (CDER) |
DCA | Direct Compounding Area (from USP <797> - Compounding Pharmacies) |
DCB | Drug-Coated Balloon |
DCB (CFSAN) | Domestic Compliance Branch (CFSAN) |
DCC | Document Control Center |
DCC (CFSAN) | Division of Cosmetics and Compliance (CFSAN) |
DCC (OC) | Division of Customer Care (OC) |
DCCA (CBER) | Division of Communication and Consumer Affairs (CBER) |
DCCT (CFSAN) | Division of Color Certification and Technology (CFSAN) |
DCD (CDRH) | Division of Cardiovascular Devices (CDRH) |
DCEPT (CBER) | Division of Clinical Evaluation and Pharmacology/Toxicology (CBER) |
DCF | Data Clarification Request Form |
DCGM (OC) | Division of Contracts and Grants Management (OC) |
DCGT (CBER) | Division of Cell and Gene Therapies (CBER) |
DCIQA (ORA) | Division of Compliance Information and Quality Assurance (ORA) |
DCIS | Design Control Inspection Strategy |
DCLD | Division of Clinical Laboratory Devices (CDRH) |
DCM (CBER) | Division of Case Management (CBER) |
DCM (CDRH) | Division of Communications Media (CDRH) |
DCMO (ORA) | Division of Compliance Management and Operations (ORA) |
DCMS (CDRH) | Division of Chemistry and Material Science (CDRH) |
DCP | Dynamic Compression Plate |
DCP (CFSAN) | Division of Cooperative Programs (CFSAN) |
DCP (NCTR) | Division of Contracts and Procurement (NCTR) |
DCP (ORA) | Division of Compliance Policy (ORA) |
DCP 1 (CDER) | Division of Clinical Pharmacology 1 (CDER) |
DCP 2 (CDER) | Division of Clinical Pharmacology 2 (CDER) |
DCP 3 (CDER) | Division of Clinical Pharmacology 3 (CDER) |
DCP 4 (CDER) | Division of Clinical Pharmacology 4 (CDER) |
DCP 5 (CDER) | Division of Clinical Pharmacology 5 (CDER) |
DCPA (CBER) | Division of Congressional and Public Affairs (CBER) |
DCR | Dynamic Condylar Screw |
DCRER (CFSAN) | Division of Chemistry Research and Environmental Review (CFSAN) |
DCRMS (CDER) | Division of Compliance Risk Management and Surveillance (CDER) |
DCRP (CDER) | Division of Cardiovascular and Renal Products (CDER) |
DCSC (OC) | Division of Construction and Service Contracts (OC) |
DCT (CDER) | Division of Counter-terrorism (CDER) |
DCTD (CDRH) | Division of Chemistry and Toxicology Devices (CDRH) |
DCU | document control unit |
DD | Division Directors in CDER or District Directors in the field |
DD | Department of Drugs (Swedish Regulatory Agency) |
DD | division director |
DD (CVM) | district director |
DDA | Division of Drug Analysis (CDER) |
DDB (CDRH) | Dental Devices Branch (CDRH) |
DDB (CDRH) | Diagnostic Devices Branch (CDRH) |
DDC | Drug Device Combination |
DDDP (CDER) | Division of Dermatology and Dental Products (CDER) |
DDDQ (CDER) | Division of Domestic Drug Quality (CDER) |
DDE | drug data entry |
DDE | dynamic data exchange |
DDES (CFSAN) | Division of Dairy and Egg Safety (CFSAN) |
DDH | Developmental Dysplasia of Hip |
DDI (CDER) | Division of Drug Information (CDER) |
DDM (NCTR) | Deputy Director for Management (NCTR) |
DDM (OC) | Division of Dockets Management (OC) |
DDMAC | Division of Drug Marketing, Advertising, and Communications |
DDMAC (CDER) | Division of Drug Marketing, Advertising and Communication (CDER) |
DDMS (CDER) | Division of Database Management and Services (CDER) |
DDMSS (CDER) | Division of Data Management Services and Solutions (CDER) |
DDOM (CBER) | Division of Disclosure and Oversight Management (CBER) |
DDOP (CDER) | Division of Drug Oncology Products (CDER) |
DDQCSS (CDER) | Division of Drug Quality and Compliance Services and Solution (CDER) |
DDR | Division Document Room |
DDRE (CDER) | Division of Drug Risk Evaluation (CDER) |
DDS | Doctor of Dental Surgery |
DDS | Deputy Director for Safety (CDER) |
DDSPC (CFSAN) | Division of Dietary Supplement Programs and Compliance (CFSAN) |
DDT | Drug Development Tools |
DE (CBER) | Division of Epidemiology (CBER) |
DE (CFSAN) | Division of Enforcement (CFSAN) |
DEIO (ORA) | Division of Emergency and Investigational Operations (ORA) |
DEMO (CDRH) | Division of Ethics and Management Operations (CDRH) |
DEN | drug experience network |
DEOD (CDRH) | Dental, Ear, Nose, Throat and Ophthalmic Devices Branch (CDRH) |
DEP | Data Evaluation Project |
DEPI (CBER) | Division of Ethics and Program Integrity (CBER) |
DEPI (CDER) | Division of Epidemiology (CDER) |
DES | Drug-Eluting Stent |
DES (CVM) | Division of Epidemiology and Surveillance (CVM) |
DES (OC) | Division of Engineering Services (OC) |
DESE (CDRH) | Division of Electrical and Software Engineering (CDRH) |
DESI | Drug Efficacy Study Implementation |
DETTD (CBER) | Division of Emerging and Transfusion Transmitted Diseases (CBER) |
DEV | Device Registration Number (ORA AofC Code) |
DFARS | Drug Firm Annual Registration Status |
DFCN (CFSAN) | Division of Food Contact Notifications (CFSAN) |
DFEM (NCTR) | Division of Facilities Engineering and Maintenance (NCTR) |
DFFI | Division of Foreign Field Investigations (ORA) |
DFLSC (CFSAN) | Division of Food Labeling, Standards, and Compliance (CFSAN) |
DFLSS | Design for Lean and Six Sigma |
DFM (NCTR) | Division of Financial Management (NCTR) |
DFMEA | Design Failure Modes and Effects Analysis |
DFO | designated federal official |
DFO (OC) | Division of Field Operations (OC) |
DFOI (OC) | Division of Freedom of Information (OC) |
DFPG (CFSAN) | Division of Field Programs and Guidance (CFSAN) |
DFPP (CFSAN) | Division of Food Processing and Packaging (Chicago, Illinois) (CFSAN) |
DFPST (CFSAN) | Division of Food Processing Science and Technology (CFSAN) |
DFRM | Drug Facility Registration Module (Furls) |
DFS | Division File System |
DFS (ORA) | Division of Field Science (ORA) |
DFSR | Division of Federal-State Relations (Office of Regulatory Affairs) |
DFSS | Design for Six Sigma |
DGCI | Drug Controller General of India (National Regulatory Body) |
DGCPC (CDER) | Division of Good Clinical Practice Compliance (CDER) |
DGFPS | Direccion General de Farmacia y Productos Sanitarios (Directorate General of Pharmacy and Sanitary Products) (Spain) |
DGIEP (CDER) | Division of Gastroenterology and Inborn Errors Products (CDER) |
DGMPA | Division of Good Manufacturing Practice Assessment (CDER) |
DGP (CDER) | Division of Gastroenterology Products (CDER) |
DGRND (CDRH) | Division of General, Restorative and Neurological Devices (CDRH) |
DGRT (NCTR) | Division of Genetic and Reproductive Toxicology (NCTR) |
DGSS (CFSAN) | Division of General Scientific Support (CFSAN) |
DH (CBER) | Division of Hematology (CBER) |
DHC | dioxin health certificate (ORA AofC code) |
DHCP | Dear Healthcare Professional (type of letter) |
DHCP | Dynamic Host Configuration Protocol |
DHF | Design History File |
DHFS (CVM) | Division of Human Food Safety (CVM) |
DHHS | Department of Health and Human Services |
DHHS | Department of Health and Human Services (U.S.) |
DHR | Design History Record |
DHR | Device History Record |
DHR | Device History Regulation |
DHR | Device History Report |
DHRD (ORA) | Division of Human Resources Development (ORA) |
DHS | Department of Human Services |
DHS | Department of Homeland Security |
DHS | Department of Homeland Security (U.S.) |
DHSS | Department of Health and Social Security (U.K.) |
DHT (CBER) | Division of Human Tissues (CBER) |
DI | Design Inputs |
DI | Device Identifier |
DI | De-Ionized |
DI | Deionized (water) |
DIA | Defense Intelligence Agency (U.S.) |
DIA | Drug Information Association |
DIAM (CDRH) | Division of Imaging and Applied Mathematics (CDRH) |
DIB | Directory, Investigations Branch |
DICOM | Digital Imaging and Communications in Medicine |
DID (CBER) | Division of Information Development (CBER) |
DIDP (CBER) | Division of Information Disclosure Policy (CDER) |
DIDQ (CDER) | Division of International Drug Quality (CDER) |
DIHD (CDRH) | Division of Immunology and Hematology Devices (CDRH) |
DIMS | Data Information Management Staff (CFSAN) |
DIMS (OC) | Division of Infrastructure Management and Services (OC) |
DIN | Deutsche Industrie Norm (German Industrial Norm) |
DIN | drug identification number (Canada) |
DIO (CBER) | Division of Information Operations (CBER) |
DIO (OC) | Division of Infrastructure Operations (OC) |
DIOP (ORA) | Division of Import Operations and Policy (ORA) |
DIOR (CDER) | Division of Import Operations and Recalls (CDER) |
DIRM (CFSAN) | Division of Information Resources Management (CFSAN) |
DIS | Draft Intemational Standard |
DIS (CBER) | Division of Inspections and Surveillance (CBER) |
DIS (CDER) | Division of Information Services (CDER) |
DIT (CDRH) | Division of Information Technology (CDER) |
DIT (NCTR) | Division of Information Technology (NCTR) |
DIVBT (CFSAN) | Division of In Vitro and Biochemical Toxicology (CFSAN) |
DIW | Deionized Water |
DJD | Degenrative Joint Disease |
DLPS (CDER) | Division of Labeling and Program Support (CDER) |
DLR | drug listing rule |
DLS | Document Logging System (CBER) |
DLS | drug listing number (ORA AofC code) |
DM | Diabetes Mellitus |
DM (CFSAN) | Division of Mathematics (CFSAN) |
DM (CFSAN) | Division of Microbiology (CFSAN) |
DM (NCTR) | Division of Microbiology (NCTR) |
DMAIC | A model for making improvements: Define, Measure, Analyze, Improve, Control |
DMAT | Disaster Medical Assistance Team |
DMAT (CBER) | Division of Manufacturers Assistance and Training (CBER) |
DMB | Dockets Management Branch |
DMB (CDER) | Division of Management and Budget (CDER) |
DMB (CFSAN) | Division of Molecular Biology (CFSAN) |
DMC | Data Monitoring Committee |
DMD | Doctor of Medicine in Dentistry |
DMD (CDRH) | Division of Microbiology Devices (CDRH) |
DME | Durable Medical Equipment |
DME | Durable Medical Equipment |
DMEDI | Define Measure Explore Develop Implement |
DMF | Drug Master File |
DMR | Device Master Record |
DMR | Discrepant Material Report |
DNA | Deoxyribonucleic Acid |
DNR | Do Not Resuscitate |
DNR | Distinctive Nutritional Requirements |
DO | Design Ouptuts |
DO | Division Directors in CDER or District Directors in the field (FDA) |
DOA | Dead on Arrival |
DoAF | Division of Planning, Analysis and Finance (CDRH) |
DOE | Design of Experiments |
DOE A (CDRH) | Division of Enforcement A (CDRH) |
DOE B (CDRH) | Division of Enforcement B (CDRH) |
DOEd | Department of Education (U.S.) |
DOED (CDRH) | Division of Ophthalmic, Ear, Nose and Throat Devices (CDRH) |
DOI | Department of the Interior (U.S.) |
DOJ | Department of Justice (U.S.) |
DOL | Department of Labor (U.S.) |
DONED | Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices (CDRH) |
DOP | Dioctylphthalate |
DOS | Department of State (U.S.) |
DOT | Department of Transportation (U.S.) |
DOT (CFSAN) | Division of Toxicology (CFSAN) |
DP | drug product |
DP (CDRH) | Division of Physics (CDRH) |
DP (NCTR) | Division of Planning (NCTR) |
DPA (CDER) | Division of Pharmaceutical Analysis (CDER) |
DPA (CDER) | Division of Public Affairs (CDER) |
DPA I (CDER) | Division of Pre-marketing Assessment I (CDER) |
DPA II (CDER) | Division of Pre-marketing Assessment II (CDER) |
DPAMS (CDER) | Division of Pre-marketing Assessment III and Manufacturing Science (CDER) |
DPAP (CDER) | Division of Pulmonary and Allergy Products (CDER) |
DPARP (CDER) | Division of Pulmonary, Allergy, and Rheumatology Products (CDER) |
DPCDO (CDER) | Division of Policy, Collaboration, and Data Operations (CDER) |
DPD (CDER) | Division of Prescription Drugs (CDER) (formerly Prescription Drugs Branch - PDB) |
DPD (CVM) | Division of Production Drugs (CVM) |
DPD (OC) | Division of Portfolio Development (OC) |
DPDD (CDER) | Division of Pediatric Drug Development (CDER) |
DPDFS (CFSAN) | Division of Plant and Dairy Food Safety (CFSAN) |
DPE (CDER) | Division of Post-marketing Development (CDER) |
DPEB (CBER) | Division of Planning, Evaluation and Budget (CBER) |
DPEM (ORA) | Division of Planning, Evaluation and Management (ORA) |
DPEPOPD (CFSAN) | Division of Programs and Enforcement Policy (OPDFB) (CFSAN) |
DPEPOS (CFSAN) | Division of Programs and Enforcement Policy (OS) (CFSAN) |
DPFRM (CFSAN) | Division of Planning and Financial Resources Management (CFSAN) |
DPHB (CFSAN) | Division of Public Health and Biostatistics (CFSAN) |
DPIC (CFSAN) | Division of Pesticides and Industrial Chemicals (CFSAN) |
DPL | Drug Product Licensing (Canada) |
DPM | Defects per Million |
DPM | Direct Part Mark |
DPMO | Defects per Million Opportunities |
DPMU | Disaster Portable Morgue Unit (PHS) |
DPP (CDER) | Division of Psychiatry Products (CDER) |
DPPS (CFSAN) | Division of Plant Product Safety (CFSAN) |
DPQ (CBER) | Division of Product Quality (CBER) |
DPQR (CDER) | Division of Product Quality Research (CDER) |
DPR (CFSAN) | Division of Petition Review (CFSAN) |
DPRF | Drug Products Reference File |
DPRF | Drug Product Reference File |
DPS (CBER) | Division of Program Services (CBER) |
DPS (CDRH) | Division of Post-marketing Surveillance (CDRH) |
DPS (CFSAN) | Division of Program Services (CFSAN) |
DPTC | PQRI Drug Product Technical Committee |
DPU | Defects per Unit |
DPV I (CDER) | Division of Pharmacovigilance I (CDER) |
DPV II (CDER) | Division of Pharmacovigilance II (CDER) |
DQ | Design Qualification |
DQ | design quality |
DQRS | Drug Quality Reporting System (CDER) |
DR | delayed release [medication] |
DR | discipline review [letter] |
DRA (CFSAN) | Division of Risk Assessment (CFSAN) |
DRARD (CDRH) | Division of Reproductive, Abdominal and Radiological Devices (CDRH) |
DRAT (CFSAN) | Division of Research and Applied Technology (CFSAN) |
DRB (CBER) | Devices Review Branch (CBER) |
DRC | Disaster Recovery Center |
DRC (CVM) | Division of Residue Chemistry (CVM) |
DRFDD (ORA) | Deputy Regional Food and Drug Director (ORA) |
DRG | diagnosis related group |
DRG | Disaster Response Group |
DRGUD | Division of Reproductive, Gastrorenal and Urology Devices (CDRH) |
DRI | daily reference intake |
DRISK (CDER) | Divison of Risk Management (CDER) |
DRLM | Device Registration and Listing Module (FURLS) |
DRLS | Drug Registration and Listing System (FDA) |
DRLS | Drug Registration and Listing System |
DRM (CDER) | Division of Records Management (CDER) |
DRM (OC) | Division of Resource Management (OC) |
DRMO (CDRH) | Division of Risk Management Operations (CDRH) |
DRMP (CDER) | Division of Review Management and Policy (CDER) |
DRP (CBER) | Division of Regulations and Policy (CBER) |
DRP I (CDER) | Division of Regulatory Policy I (CDER) |
DRP II (CDER) | Division of Regulatory Policy II (CDER) |
DRPM | dispute resolution project manager |
DRR (NCTR) | Deputy Director for Research (NCTR) |
DRRDSSS (CDER) | Division of Regulatory Review and Drug Safety Services and Solutions (CDER) |
DRUP (CDER) | Division of Reproductive and Urologic Products (CDER) |
DRV | daily reference value |
DS | Drug Substance |
DS (CVM) | Division of Surveillance (CVM) |
DSAC (CBER) | Division of Scientific Advisors and Consultants (CBER) |
DSATOS (CFSAN) | Division of Science and Applied Technology (OS) (CFSAN) |
DSB | Drug Safety Oversight Board |
DSC | Differential Scanning Calorimeter |
DSC | Data Standards Council (FDA) |
DSC | Drug Safety Communication |
DSC (CDER) | Division of Safety Compliance (CDER) |
DSCI (CDER) | Division of Supply Chain Integrity (CDER) |
DSCI (OC) | Division of Systems, Compliance and IMPAC (OC) |
DSDB (CDRH) | Diagnostic and Surgical Devices Branch (CDRH) |
DSFM (CDRH) | Division of Solid and Fluid Mechanics (CDRH) |
DSI (CDER) | Division of Scientific Investigation (CDER) |
DSM | Data Standards Manual (CDER) |
DSMB | Data Safety Monitoring Board |
DSMICA (CDRH) | Division of Small Manufacturers, International and Consumer Assistance (CDRH) |
DSMZ | Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH (German Collection of Microorganisms and Cell Cultures) |
DSORD | Division of Surgical, Orthopedic, And Restorative Devices (CDRH) |
DSP | Downstream Processing |
DSP | Desktop Standardization Project |
DSP (OC) | Division of Strategic Projects (OC) |
DSPTP (CDER) | Division of Special Pathogen and Transplant Products (CDER) |
DSRCS (CDER) | Division of Surveillance, Research and Communication Support (CDER) |
DSRIT (CFSAN) | Dietary Supplement Regulations Implementation Team (CFSAN) |
DSS | Decision Support System |
DSS (CDRH) | Division of Surveillance Systems (CDRH) |
DSTC | PQRI Drug Substance Technical Committee |
DTBIMP (CDER) | Division of Therapeutic Biological Internal Medicine Products (CDER) |
DTBOP (CDER) | Division of Therapeutic Biological Oncology Products (CDER) |
DTC | direct-to-consumer |
DTD | Device Tracking Database |
DTD | document type definition (for electronic interchange) |
DTD (CDER) | Division of Training and Development (CDER) |
DTR | Deep Tendon Reflex |
DUNS | Data Universal Numbering System |
DUPSA (CDRH) | Division of Device User Programs and System Analysis (CDRH) |
DUR | drug utilization review |
DUSM | Deputy United States Marshal (U.S. Department of Justice) |
DV | Design Validation |
DV | daily value |
DVA (CFSAN) | Division of Virulence Assessment (CFSAN) |
D-value | Decimal Reduction Time (log-linear kill kinetics) |
DVD | Dissociated Vertical Deviation |
DVT | Deep Venous Thrombosis |
DW | Data Warehouse |
E2B | Efficacy Topics' Data Elements for Transmission of Adverse Drug Reactions Reports (ICH) |
EA | Environmental Assessment |
EA | environmental assistance |
EAB | Ethics Advisory Board |
EAB (CFSAN) | Exposure Assessment Branch (CFSAN) |
EAC | Expert Advisory Committee (Canada) |
EAFUS | Everything Added to Food in the United States |
EAR | Export Administration Regulations (U.S. Department of Commerce) |
EAS | Emergency Alert System |
EAS (CDER) | Enterprise Architecture Staff (CDER) |
EASE | Enterprise Administrative Support Environment |
EB (CDRH) | Epidemiology Branch (CDRH) |
EB (NCTR) | Engineering Branch (NCTR) |
EBAA | Eye Bank Association of America |
EBKAR | Error Between Keyboard and Chair (Data Entry Error) |
eBPDR | Electronic Biological Product Deviation Reporting |
EBR | Electronic Batch Record |
EBS | Emergency Broadcast System |
EC | European Commission |
EC | European Community |
ECBS | Expert Committee on Biological Standardization (WHO) |
eCDT | Electronic Common Technical Document (ICH M2 [Multi-disciplinary Group 2] EWG [Expert Working Group]) |
ECE | Economic Commission for Europe |
ECG | Electrocardiogram |
ECMO | Extracorporeal Membrane Oxygenation |
ECP | Essential Community Provider |
ECQ | Executive Code Qualifications |
eCRF | electronic case report form |
e-CRF | electronic case report form |
ECRI | Emergency Care Research Institute (no longer uses name initials only) |
ECRS (CFSAN) | Emergency Coordination and Response Staff (CFSAN) |
ECS (OC) | Economics Staff (OC) |
eCTD | Electronic Common Technical Document |
ECU | European Currency Unit |
EDC | Electronic Data Capture |
EDMA | European Diagnostic Manufacturers Association |
EDMS | Electronic Document Management System |
EDQM | European Directorate for the Quality of Medicines & Healthcare |
EDX | Energy Dispersive X-Ray Spectroscopy |
EEA | European Economic Area |
EEC | European Economic Community |
EEC | European Economic Community |
EEG | Electroencephalogram |
EFPIA | European Federation of Pharmaceutical Industries Associations |
EFR | Early Failure Rate |
EFTA | European Free Trade Association |
EHB | Essential Health Benefits |
EHEC | Enterohaemmorrhagic E. Coli |
EHS | Environmental Health and Safety |
EID | Electronic Identification Device |
EIR | Establishment Inspection Report |
EIS | Environmental Impact Statement |
EKG | Electrocardiogram |
ELA | Establishment License Application |
ELISA | Enzyme Linked Immunosorbent Assay |
eLIST | Electronic Listing System |
ELN | Electronic Laboratory Notebook |
EM | Environmental Monitoring |
EM | Electron Microscopy |
EMA | European Medicines Agency |
EMA | European Medicines Agency (aka EMEA) |
EMB | Eosin Methylene Blue |
EMC | Electromagnetic Compatibility |
EMEA | European Medicines Agency (aka EMA) |
EMG | Eletrcomyogram |
EMI | Electro-Magnetic Interference |
EMR | Electronic Medical Record |
EMS | Electromagnetic Spectrum |
EMV | Eye-Motor-Verbal (Glasgow Coma Scale) |
EO | Ethylene Oxide |
EO | Executive Order |
EOB | Explanation of Benefits |
EOG | Electrooculogram |
EOM | Extraocular Muscle |
EP | Electrophysiology |
EP | European Pharmacopoeia |
EPA | U.S. Environmental Protection Agency |
EPF | Effective Patent Life |
EPO | Exclusive Provider Organization |
EPSDT | Early Periodic Screening, Diagnostic & Treatment Services |
EQ | Equipment Qualification |
ER | Emergency Room |
ER | Essential Requirements |
ER | Equipment Reliability |
ER | Extended release |
ERG | Erg Electroretinogram |
ERISA | Employee Retirement Income Security Act |
ERM | Enterprise Risk Management |
ERP | Enterprise Resource Planning |
ERR | Entry Review Recommended (ORA AofC Code) |
ES | Effect Size |
ESD | Electro-Static Discharge |
ESI | Employer-sponsored Insurance |
ESO | Equipment Superior to Operator (IT expression for equipment repair issue) |
ESTRI | Electronic Standards for The Transfer of Regulatory Information |
EtO | Ethylene Oxide |
EU | European Union |
EU MDD | European Union’s Medical Device Directive, Council Directive 93/42/EEC of 14 June 1993, as amended |
EUCOMED | European Confederation of Medical Devices Associations |
EUDAMED | European Database on Medical Devices |
EUMDR | European Union Medical Device Regulation |
EUREPGAP | Euro-Retailer Product Working Group Gap |
EVH | Endoscopic Vein Harvest |
FA | Failure Analysis |
FA | Filing Action |
FA | First Article |
FACA | Federal Advisory Committee Act |
FACR | Fellow of American College of Radiology |
FACS | Fellow of American College of Surgeons |
FAI | First Article Inspection |
FAI | Further Action Indicated |
FAO | Food and Agriculture Organization (Part of UN) |
FAO | Food and Agriculture Organization of the United Nations (USDA affiliate) |
FAR | Federal Acquisition Regulations |
FAR | Field Alert Reports |
FAS | Fetal Alcohol Syndrome |
FAS | Foreign Agricultural Service |
FAS | foreign Agricultural Service (Part of USDA) |
FAT | Factory Acceptance Test |
FAT | Factory Acceptance Testing |
FB | Foreign Body |
FCCSET | Federal Coordinating Council for Science, Engineering and Technology |
FCO | Federal Coordinating Officer |
FD&C | Food, Drug & Cosmetic (Act) |
FD&C Act | Food Drug and Cosmetics Act |
FD&C Act | Food, Drug and Cosmetic Act |
FDA | Food and Drug Administration |
FDA 482 | Federal form for announcing intention of FDA to inspect a facility |
FDA 483 | Establishment Inspection Report issued on Form 483 |
FDA 483 | Form for listing FDA inspectional citations |
FDAMA | FDA Modernization Act |
FDAMA | Food and Drug Administration Modernization Act |
FDARA | Food and Drug Administration Reauthorization Act |
FDASIA | Food and Drug Administration Safety and Innovation Act |
FDIS | Final Draft International Standard |
FEB | Federal Executive Board |
FEMA | Federal Emergency Management Agency |
FFE | Federally Facilitated Exchange |
FFM | Federally Facilitated Marketplace |
FFS | Fee-for-service |
FI | Food Inspector |
FIFO | First In First Out |
FIFO | First In, First Out |
FIREBIRD | Federal Investigator Registry for Bioinformatics Research Data |
Fluid-D | Diluting Fluid D (Sterility Test; peptone w/polyysorbate 80) |
FM | Failure Mode |
FMEA | Failure Modes and Effects Analysis |
FMEA | Failure Mode Effects Analysis |
FMEA | failure modes and effect analysis |
FMECA | Failure Modes Effects and Criticality Analysis |
FMECA | Failure Mode, Effects, and Criticality Analysis |
FMI | Food Marketing Institute |
FMIA | Federal Meat Inspection Act |
FMLA | Family and Medial Leave Act |
fMRI | Functional Magnetic Resonance Imaging |
FNDDS | Food and Nutrient Database for Dietary Studies |
FNS | Food and Nutrition Service |
FNS | Food and Nutrition Service |
FOB | federal office building |
FOB | Free On Board |
FOD | Foreign Object Debris |
FOD | Foreign Object Damage |
FOI | freedom of information |
FOIA | Freedom of Information Act |
FOIB (CDRH) | Freedom of Information Branch (CDRH) |
FONSI | Finding of No Significant Impact |
FOP | financial operating plan |
FPAP | First-person Audit Program |
FPIF | Finnish Pharmaceutical Industry Association |
FPL | Federal Poverty Level |
FPL | final printed label |
FPLA | Fair Packaging and Labeling Act (1967) |
FPLP | Federal Premier Lodging Program |
FPS | Federal Protective Service (Department of Homeland Security) |
FPVST (OC) | Facilities Planning and Voice Services Team (OC) |
FPY | First Pass Yield |
FQHC | Federally Qualified Health Center |
FR | Federal Register |
FRACAS | Failure Reporting and Corrective Action System |
FRB | Failure Review Board |
FRC | Federal Records Center (Suitland) |
FRC | functional residual capacity |
FRCS | Fellow of Royal College of Surgeons |
FRDTS | Federal Register Document Tracking System |
FRP | Federal Response Plan (FEMA) |
FS | feasibility study |
FS | federal standard (U.S.) |
FSA | Flexible Spending Account |
FSCA | Field Safety Corrective Action |
FSIS | Food Safety and Inspection Service |
FSIS | Food Safety and Inspection Service (Part of USDA) |
FSIS | Food Safety and Inspection Service |
FSMA | Food Safety Modernization Act |
FSMP | Food for Special Medical Purpose |
FSRC | Food Safety Research Consortium |
FTA | Fault Tree Analysis |
FTD | Failure Tree Diagram |
FTE | full-time equivalent |
FTE | Full Time Equivalent |
FTIM | first time in man |
FTIR | Fourier Transform Infrared Spectroscopy |
FT-IR | Fourier Transform Infrared Spectroscopy |
FTM | Fluid Thioglycollate Medium |
FTP | file transfer protocol |
FTQ | First Time Quality |
FTR | Federal Travel Regulations |
FTS | Federal Telecommunications System |
FTT | Failure to Thrive |
FTTA | Federal Technology Transfer Act |
FUBAR | Fouled Up Beyond All Recognition |
FWB | Full Weight Bearing |
FX | Fracture |
FY | Fiscal Year |
GAMP | Good Automated Manufacturing Practices |
GAP | Good Agricultural Practices |
GAqP | Good Aquaculture Practices |
GC | Gas Chromatography |
GCLP | Good Control Laboratory Practice (European GMP term) |
GCP | Good Clinical Practice |
GCP | Good Clinical Practices |
GCP | Good Compounding Practice |
GD&T | Geometric Dimensioning and Tolerancing |
GDF | Generic Drugs Forum |
GDP | Good Documentation Practices |
GDP | Good Distribution Practices |
GDT | Geometric Dimensioning and Tolerancing |
GDUFA | Generic Drug User Fee Act |
GDUFA | Generic Drug User Fee Amandments |
GE | Gentically Engineered (Food or Product) |
GE | Genetically Engineered |
GEM | Genetically Engineered Microorganism |
GERM | Good Electronic Records Management |
GGP | Good Guidance Practices |
GHP | Good Handling Practices |
GHTF | Global Harmonization Task Force |
GHz | Gigahertz |
GI | Gastrointestinal |
GIGO | Garbage In, Garbage Out (bad data leads to bad conclusions) |
GLP | Good Lab Practices |
GLP | Good Laboratory Practice |
GMA | Grocery Manufacturers Association |
GMDN | Global Medical Device Nomenclature |
GMO | Genetically Modified Organism |
GMP | Good Manufacturing Practices |
GMP | Good Manufacturing Practice |
GNC | Gram Negative Cocci |
GNR | Gram Negative Rods |
GPC | Gram Positive Cocci |
GPM | General Purpose Medium |
GPO | Group Purchasing Organization |
GPQ | Growth Promoting Quality |
GPR | Gram Positive Rods |
GPRA | Government Performance and Results Act |
GPT | Growth Promotion Test |
GR&R | Gage Reproducibility and Repeatability |
GRAS | Generally Recognized As Safe |
GRASE | Generally Recognized as Safe and Effective |
GRP | Good Review Practice |
GTM | Go To Market |
GTP | Good Tissue Practices |
GVC | Gram Variable Cocci |
GVR | Gram Variable Rods |
GW | Gross Weight |
GxP | Good xxxx Practice (see GMP or GLP or GCP) |
Gy | Gray (Radiation) |
H0 | Null Hypothesis |
H1 | Alternate Hypothesis |
HA | Hydroxyapatite |
HA | Hyaluronic Acid |
Ha | Alternate Hypothesis |
HACCP | Hazard Analysis and Critical Control Point |
HACCP | Hazard Analysis and Critical Control Points |
HAFO | Hinged Ankle Foot Orthosis |
HAI | Hospital Acquired Infection |
HAI | Healthcare Associated Infection |
HALT | Highly Accelerated Life Test |
HAP | Hydroxyapatite |
HAS | Hospital Automation System |
HAZOP | Hazard and Operability Study |
HAZOP | Hazard Operability Analysis |
HbF | Fetal Hemoglobin |
HC | Health Canada |
HCBS | Home and Community-Based Services |
HCR | Health Care Reform |
HDHP | High Deductible Health Plan |
HDL | High density lipo-protein |
HDPE | High Density Polyethylene |
HEART | Human Error Assessment and Reduction Technique |
HEPA | High Energy Particulate Air |
HEPA | High Efficiency Particulate Air filters |
HF | Heart Failure |
HFSA | Heart Failure Society of America |
HGH | Human Growth Hormone |
HHS | U.S. Department of Health and Human Services |
HIE | Hypoxic-Ischemia Encephalopathy |
HIM | Health Insurance Marketplace |
HIPAA | Health Insurance Portability and Accountability Act |
HIPAA | Health Insurance Portability and Accountability Act |
HIS | Internal Hip Syndrome |
HIX | Health Insurance Exchange |
HMD | Hyaline Membrane Disease |
HME | Hot Melt Extrusion |
HMO | Health Maintenance Organization |
HO | History of |
Ho | Null Hypothesis |
HPAPI | High Potency Active Pharmaceutical Ingredient |
HPB | Health Protection Branch (Canada) |
HPC | Heterotrophic Plate Count |
HPFB | Health Products and Food Branch (Health Canada) |
HPI | History of Patient Illness |
HPLC | High Performance Liquid Chromatography |
HRI | Human Readable Interpretation |
HRP | High Risk Pool |
HRSA | Health Resources and Services Administration |
HRT | Hormone Replacement Therapy |
HSA | Health Savings Account |
HSS | Hospital for Special Surgery |
HTA | Health Technology Assessment |
HTN | Hypertension |
HTS | High Throughput Screening |
HUD | Humanitarian Use Device |
HVAC | Heating, Ventilation and Air Conditioning |
Hz | Hertz |
I & D | history |
I & O | incision and drainage |
I&D | Incision and Drainage |
IA | intake and output |
IAB (CDRH) | Import Administration (U.S. Department of Commerce) |
IAB (ORA) | Information and Analysis Branch (CDRH) |
IABP | Intra-Aortic Balloon Pump |
IACUC | Infrastructure Applications Branch (ORA) |
IAG | Institutional Animal Care and Use Committee |
IAL | Interagency Agreement |
IARC | International Agency for Research on Cancer (WHO) |
IAS (CFSAN) | Industry Activities Staff (CFSAN) |
IAS (CFSAN) | International Affairs Staff (CFSAN) |
IAS (OC) | International Agreements Staff (OC) |
IAST (CFSAN) | International Activities Staff (CFSAN) |
IATA | International Air Transport Association |
IAVG | Interagency Vaccine Group |
IAW | in accordance with |
IB | Investigator's Brochure |
IB (CFSAN) | Immunobiology Branch (CFSAN) |
IB (ORA) | International Branch (ORA) |
IBB (CFSAN) | Instrumentation and Biophysics Branch (CFSAN) |
IBD | Inflammatory Bowel Disease |
IC | informed consent |
ICA | intelligent console architecture |
ICA | inter-Center agreement |
ICAM | International Cooperative Agreements Manual |
ICAO | International Civil Aviation Organization |
ICB (CDRH) | Inspection and Compliance Branch (CDRH) |
ICB (CFSAN) | Implementation and Compliance Branch (CFSAN) |
ICCBBA | International Council for Commonality in Blood Banking Automation, Inc. |
ICCCS | International Confederation of Contamination Control Societies |
ICCVAM | Interagency Coordinating Committee on Validation of Alternative Methods |
ICD | Implanatable Cardioverter Defibrillator |
ICD | informed consent document |
ICD-9-CM | International Classification of Diseases, Ninth Revision, Clinical Modification |
ICDB (CDRH) | Infection Control Devices Branch (CDRH) |
ICDB (CDRH) | Interventional Cardiology Devices Branch (CDRH) |
ICDRA | International Conference of Drug Regulatory Authorities |
ICE | Immigration and Customs Enforcement (Department of Homeland Security) |
ICF | Informed Consent Form |
ICH | International Conference on Harmonization |
ICH | International Conference on Harmonisation (of Technical Requirements for Registration of Pharmaceuticals for Human Use) |
ICIB (CDRH) | Intraocular and Corneal Implants Branch (CDRH) |
ICLAS | International Council for Laboratory Animal Science |
ICMJE | International Committee of Medical Journal Editors |
ICPEMC | International Commission for Protection Against Environmental Mutagens and Carcinogens |
ICRP | International Commission on Radiological Protection |
ICRU | International Commission on Radiation Units and Measurements |
ICS | Incident Command System |
ICSR | Individual Case Safety Reports |
ICTAP | Interagency Career Transition Assistance Plan |
ICU | Intensive Care Unit |
ID | Identification |
ID10T | Idiot (the ID10T error is commonly found by IT professionals) |
IDC | Information and Data Committee |
IDDM | Insulin-Dependent Diabetes Mellitus |
IDE | Investigational Device Exemption |
IDE | investigational device exemption (CDRH) |
IDE | investigational device exemption number (ORA AofC code) |
IDE (CDRH) | Investigational Device Exemptions Sections (CDRH) |
IDIQ | indefinite-delivery, indefinite-quantity [contracts] |
IDL | international date line |
IDM | Informational Disclosure Manual |
IDMP | Identification of Medicinal Products |
IDOV | Identify Design Optimize Validate |
IDP | individual development plan |
IEC | International Electrotechnical Commission |
IEC | Independent Ethics Committee (DHHS) |
IEC 60601 | A series of standards from the International Electrotechnical Commission for safety and performance as applicable to Medical Electrical Equipment |
IEE | intervention effect estimate |
IEEE | Institute of Electrical and Electronics Engineers |
IEST | Institute for Environmental Sciences and Technology |
IFA | investigational food additive (file) |
IFAD | International Food Additives Database (CFSAN) |
IFE | import for export (ORA AofC code) |
IFIC | International Food Information Council |
IFIP | International Federation for Information Processing |
IFMFS (CFSAN) | Infant Formula and Medical Foods Staff (CFSAN) |
IFPMA | International Federation of Pharmaceutical Manufacturers Associations |
IFSAC | Interagency Food Safety Analytics Collaboration |
IFT | Institute of Food Technologists |
IFU | Instructions for Use |
IHI | Institute for Healthcare Improvement |
IIMB (CDRH) | IT Infrastructure Management Branch (CDRH) |
IIMG | Interagency Incident Management Group |
IIS | internet information officer |
IK | Improvement Kata |
IM | Intra Muscular |
IM | Intra Medullary |
IMB | Irish Medicines Board |
IMB (CDER) | Interface Management Branch (CDER) |
IMB (CDRH) | Information Management Branch (CDRH) |
IMC | Information Management Consultants, Inc. |
IMCC | Information Management Coordinating Committee (CBER) |
IMD | Implantable Medical Device |
IMDA | Irish Medical Device Association |
IMDB (CDRH) | Immunology and Molecular Diagnostics Devices Branch (CDRH) |
IMDG | International Maritime Dangerous Goods Code |
IMDRF | International Medical Device Regulators Forum |
IMLS | Institute of Museum and Library Services |
IMO | International Maritime Organisation |
IMP | investigational medicinal product |
IMPAC | Information for Management, Planning, Analysis and Coordination |
IMPAC | International Merchant Purchase Authorization Card |
IMPD | Investigational Medicinal Product Dossier (EU) |
IMR Chart | An SPC Chart based on Individual Measurements and Range |
IMS | Information Management System |
IMS (CDRH) | Issues Management Staff (CDRH) |
IMT | Incident Management Team |
IMT | International Medical Terminology |
IMTS | Industry Meeting Tracking System |
IND | Investigational New Drug |
IND | investigational new drug application |
IND | investigational new drug number (ORA AofC code) |
INDA | Investigational New Drug Application |
INDC | Investigational New Drug Committee |
INFARME D | Instituto Nactional da Farmaciae e do Medicamento (Portugal) |
INN | International Nonproprietary Name |
INN | International Approved Names for Pharmacopoeial Substances |
INNS | International Neural Network Society |
INS | incident of national significance |
INV sample | investigational sample |
IO | Immediate Office |
IOB | International Operations Branch (ORA) |
IOM | Institute of Medicine |
IOM | Investigations Operations Manual (FDA) |
IOM | Institute of Medicine of the National Academies |
IOM | Investigation Operations Manual |
IOTF | Interagency Oncology Task Force (FDA and NCI) |
IP | Intellectual Property |
IP | information panel |
IP | internet protocol |
IPA | In-Person Assisters Program |
IPA | Isopropyl Alcohol |
IPC | In-process Control |
IPC | in process control |
IPC | incidental patient contact |
IPCB (CDER) | Investigations and Preapproval Compliance Branch (CDER) |
IPCS | International Programme on Chemical Safety (WHO) |
IPEC | International Pharmaceutical Excipients Council |
IPM | Import Program Manager |
IPO | initial public offering |
IPOAB (CDRH) | Information Processing and Office Automation Branch (CDRH) |
IPPC | International Plant Protection Convention |
IPPIA | International Plasma Products Industry Association |
IPRMS (OC) | International Planning and Resource Management Staff (OC) |
IPRO | Independent Pharmaceutical Research Organization |
IPS (OC) | IMPAC Program Staff (OC) |
IPS (OC) | International Policy Staff (OC) |
IPT | Integrated Project Team |
IPU | Irish Pharmaceutical Union |
IQ | Installation Qualification |
IQC | Incoming Quality Control |
IQMP | Integrated Quality Management Plan |
IQR | Inter-quartile Range |
IR | Infra-red |
IR | Interventional Radiology |
IR | Immediate Release |
IR | information request |
IRA | immediate response authority |
IRA | Investigational and Related Application |
IRB | Investigational Review Board |
IRB | Institutional Review Board |
IRC | Institutes Review Committee |
IRC | impact resistance lens certification (ORA AofC code) |
IRC | internet relay chat |
IREAS (CDRH) | International Relations and External Affairs Staff (CDRH) |
IRIS | International Regulatory Issues Staff (ORA) |
IRM | information resources management |
IRMC | Information Resources Management College |
IRS | identical, related, or similar |
IRS | Incident Reporting System |
IRS | Internal Revenue Service (U.S. Department of the Treasury) |
IRS (OC) | International Relations Staff (OC) |
IRTA | Intramural Research Training Award (NIH) |
IS | interstate commerce |
ISA | information systems architecture |
ISAC | Information Sharing and Analysis Center |
ISASS (OC) | International Scientific Activities and Standards Staff (OC) |
ISB (CDRH) | Inspection Support Branch (CDRH) |
ISBT | International Society of Blood Transfusion |
ISBT 128 | International Society of Blood Transfusion standard for blood, tissue, and organ identification |
ISDN | Integrated Services Digital Network |
ISE | integrated summary of efficiency |
ISIS | Import Support and Information System |
ISMP | Institute for Safe Medication Practices |
ISO | International Standards Organization |
ISO | International Organization for Standardization |
ISO 13485 | International Standard for Quality Management Systems applicable to companies engaged in Medical Devices |
ISO 14971 | International Standard applicable to Risk Management as it applies to Medical Devices |
ISP | internet service provider |
ISPE | International Society for Pharmaceutical Engineering |
ISPE | International Society for Pharmacoepidemiology |
ISR | Individual Safety Report |
ISS | Integrated Summary of Safety |
ISS/ISE | integrated summary of safety and effectiveness |
ISSO | information systems security officer |
IT | Inspiratory Time |
IT | Information Technology |
ITA | International Trade Administration |
ITACS | Import Trade Auxiliary Communication System |
ITAS | Integrated Time and Attendance System |
ITATMT (OC) | IT Asset Tracking and Management Team (OC) |
ITB (CFSAN) | Immunotoxicology Branch (CFSAN) |
ITC | International Trade Commission (U.S.) |
ITCB (OC) | Information Technology Contracts Branch (OC) |
ITCC | Information Technology Coordinating Committee (CDER) |
ITDS | International Trade Data System |
ITF | Inspection Task Force (CBER) |
ITGS (OC) | IT Governance Staff (OC) |
ITIC | Information Technology Implementation Committee (CBER) |
ITIM | Information Technology Investment Management |
ITIPS | Information Technology Investment Portfolio System |
ITIRB | Information Technology Investment Review Board |
ITMRA | Information Technology Management Reform Act (now the Clinger-Cohen Act) |
ITS (CBER) | Information Technology Staff (CBER) |
ITT | intent to treat |
ITTT (OC) | IT Training Team (OC) |
IUO | investigation use only |
IUPAC | International Union of Pure and Applied Chemistry |
IV | Intra Venous |
IV | intravenous |
IV & V | independent verification and validation |
IV/IVC | In vitro / In vivo Correlation |
IVC | Inferior Vena Cava |
IVD | In Vitro Diagnostic (Device or Product) |
IVD | In vitro Diagnostics |
IVDD | In Vitro Diagnostic Device Directive |
IVD-IR/-MR | In vitro dissolution-immediate release or modified release products |
IVDR | Invitro Diagnostic Regulation |
IVMD | in vitro medical device |
IVP | intravenous pyelogram |
IVT | Intraventricular Hemorrhage |
IVTB (CFSAN) | In Vitro Toxicology Branch (CFSAN) |
J/D | judgment for the defendant |
JAAOS | Journal of American Academy of Orthopedic Surgeons |
JAD | joint application development |
JAMA | The Journal of American Medical Association |
JAN | Japanese Adopted Names |
J-ART | Japanese Adverse Reaction Terminology |
JBIG | Joint Bi-level Image Experts Group |
JBJS | Journal of Bone and Joint Surgery |
JBJS | Journal of Bone and Joint Surgery |
JBMR | Journal of Bone and Mineral Research |
JCAHO | Joint Commission on Accreditation of American Health Care Organizations (aka Joint Commission) |
JCAHO | Joint Commission on Accreditation of Health Care Organizations |
JCM | Japanese Collection of Microorganisms |
JECFA | Joint (FAO/WHO) Expert Committee on Food Additives |
JFHQ | Joint Force Headquarters |
JFO | Joint Field Office |
JFTR | Joint Federal Travel Regulations |
JIC | Joint Information Center |
JIFSAN | Joint Institute for Food Safety and Applied Nutrition |
JIFSAN (CFSAN) | JIFSAN Liaison Staff (CFSAN) |
JIT | Just in Time |
JITT | Just in Time Training |
JLCS (OC) | Jefferson Laboratory Complex Staff (OC) |
JMO | Japanese Maintenance Organization |
JMPR | Joint FAO/WHO Meeting of Pesticide Residues |
JP | Japanese Pharmacopoeia |
JPEG | Joint Photographic Experts Group |
JPMA | Japanese Pharmaceutical Manufacturers Association |
JPMA | Japan Pharmaceutical Manufacturers Association |
JRIES | Joint Regional Information Exchange System |
JTF | Joint Task Force |
JTR | Joint Travel Regulations |
kGy | Kilogray (Radiation) |
KHN | Kaiser Health News |
KISS | Keep It Simple, Stupid |
KIV | Key Input Variable |
KMT (OC) | Knowledge Management Staff (OC) |
kN | Kilonewtons |
KN | Kilo Newtons |
KOS | knowledge organization system |
KOV | Key Output Variable |
kPa | Kilo Pascals (Pressure) |
KPa | Kilo Pascals |
KPI | Key Performance Indicator |
KPP | Key Process Parameter |
KSF | Key Success Factor |
KVP | Kilo Volts Peak |
LA | Lead Auditor |
LADP | Locally-acting drug products |
LAF | Laminar Air Flow |
LAL | Limulous Amoebocyte Lysate (Bacterial Endotoxin Test) |
LAN | local area network |
LanguaL | Langua Alimentaria (Language of Foods) |
LAR | licensing action recommendation |
LARD | licensing action recommendation document |
LARM | Licensing Action Recommendation Memorandum |
LAS | Laboratory Automation System |
LASA | Linear Analog Self-Assessment Measure |
LATS | License Application Tracking System |
LBL | Ernest Orlando Lawrence Berkeley National Laboratory |
LBP | Lower Back Pain |
LBP (CBER) | Laboratory of Bacterial Polysaccharides (CBER) |
LBPUA (CBER) | Laboratory of Bacterial, Parasitic and Unconventional Agents (CBER) |
LBVB (CBER) | Laboratory of Biochemistry and Vascular Biology (CBER) |
LC | Least Count |
LC/GC | Liquid Chromatography/Gas Chromatography |
LCDC | Laboratory Centre for Disease Control (Canada) |
LCH (CBER) | Laboratory of Cellular Hematology (CBER) |
LCI | Livestock Conservation Institute |
LCL | Lower Control Limit |
LCP (CDER) | Laboratory of Clinical Pharmacology (CDER) |
LCT (CFSAN) | Labeling Compliance Team (CFSAN) |
LD | lethal dose |
Ld50 | Lethal Dose 50 |
LDL | Low density lipo-protein |
LDT | Laboratory Developed Test |
LDV (CBER) | Laboratory of DNA Viruses (CBER) |
LEAA | Law Enforcement Alliance of America |
LECC | Law Enforcement Coordination Committee |
LER | Low Endotoxin Recovery effect |
LERN | Library Electronic Reference Network |
LES | leave and earnings statement |
LESTD (CBER) | Laboratory of Enteric and Sexually Transmitted Diseases (CBER) |
LF | low frequency |
LFH | Laminar Flow Hood |
LH (CBER) | Laboratory of Hemostasis (CBER) |
LHREA (CBER) | Laboratory of Hepatitis and Related Emerging Agents (CBER) |
LHV (CBER) | Laboratory of Hepatitis Viruses (CBER) |
LI | learned intermediary |
LIB (CBER) | Laboratory of Immunobiochemistry (CBER) |
LIFO | Last In First Out |
LIMS | Laboratory Information Management System |
LIR (CBER) | Laboratory of Immunoregulation (CBER) |
LIS | Laboratory Information System |
LLQ | Left Lower Quadrant |
LMD (CBER) | Laboratory of Method Development (CBER) |
LMDCI (CBER) | Laboratory of Mycobacterial Diseases and Cellular Immunology (CBER) |
LMDQC (CBER) | Laboratory of Methods Development and Quality Control (CBER) |
LMO | living modified organism |
LMS | Learning Management System |
LMS | Laboratory Management System or Laboratory Management Software |
LMS | Laboratory Management System |
LMV (CBER) | Laboratory of Molecular Virology (CBER) |
LN | Natural Logarithm |
LNC | Labeling and Nomenclature Committee (CDER) |
LNE | Laboratoire National de Metrologie et d'Essias (National Laboratory of Metrology and Essays) |
LOA | letter of agreement |
LOAEL | Lowest Observed Adverse Effect Level |
LOB (ORA) | Laboratory Operations Branch (ORA) |
LOC | Limit of Detection |
LOC | Lab-on-a-Chip |
LOC | level of concern |
LOCF | last observation carried forward |
LOD | Limit of Detection |
LOEL | Lowest Observed Effect Level |
LOG | Logarithm |
LOI | Letter of Intent |
LOINC | Logical Observation Identifier Name Codes (Regenstrief Institute) |
LOQ | Limit of Quantification |
LOV | list of values (EASE) |
LP | Light Perception |
LPB (OC) | Leasing and Policy Branch (OC) |
LPD (CBER) | Laboratory of Plasma Derivatives (CBER) |
LPET (CFSAN) | Laboratory Proficiency and Evaluation Team (CFSAN) |
LPO | Light Perception Only |
LPRVD (CBER) | Laboratory of Pediatric and Respiratory Viral Diseases (CBER) |
LPS | Lipopolysaccharide |
LPT (CFSAN) | Liaison and Policy Team (CFSAN) |
LRA | local registration authority |
LRB (CDER) | Labeling Review Branch (CDER) |
LRC | Lipid Research Clinic |
LRIS | Lot Release Imaging System |
LRIT (CFSAN) | Labeling Regulations Implementation Team (CFSAN) |
LRN | Laboratory Response Network (CDC) |
LRP | low regulatory priority |
LRPDB (CDRH) | Labeling Research and Policy Development Branch (CDRH) |
LRS | Lot Release System |
LRSP (CBER) | Laboratory of Respiratory and Special Pathogens (CBER) |
LRW | LAL Reagent Water |
LS | Labelling Standard (Canada) |
LS (CDRH) | Library Staff (CDRH) |
LS/LS | life supporting/life sustaining |
LSL | Lower Specification Limit |
LSS | Lean Six Sigma |
LST | device listing number (ORA AofC code) |
LTC | Long Term Care |
LTE | Less Than Effective |
LTPD | Lot Tolerance Percent Defective |
LUACRG | Lung and Upper Aerodigestive Cancer Research Group |
LUQ | Left Upper Quadrant |
LVAD | Left Ventricular Assist Device |
LVBD (CBER) | Laboratory of Vector-Borne Diseases (CBER) |
LVCH | local voucher |
LVN | Licensed Vocational Nurse |
LVP | Large Volume Parenteral |
LWC | electrode lead wire or patient cable (ORA AofC code) |
LWOP | leave without pay |
M&A | Mergers and Acquisition |
M&IE | miscellaneous and incidental expenses |
M&R | Maintenance and Repair |
M/H | Medical History |
M2 | ICH M2 Expert Working Group (EWG) [electronic standards for transmission of regulatory information] |
M204 | Model 204 Database Management System (Computer Corporation of America) |
M4 | ICH M4 Expert Working Group (EWG) [focusing on Common Technical Documents for sections of the NDA] |
MA | Medicare Advantage |
MA | Marketing Authorisation |
MAA | Marketing Authorisation Application |
MAb | Monoclonal Antibody |
MAB (CDER) | Management Analysis Branch (CDER) |
MAB (CFSAN) | Methods Application Branch (CFSAN) |
MAC | MacConkey Agar |
MACB | MacConkey Broth |
MACMIS | Marketing, Advertising and Communication Management Information System |
MACS (CBER) | Manufacturers Assistance and Communications Staff (CBER) |
MAGI | Modified Adjusted Gross Income |
MAH | Marketing Authorization Holder |
MAH | Marketing Authorisation Holder (EC) |
MALDI-TOF | Matrix-assisted laser desorption/ionization Time-of-flight |
MANOVA | Multivariate Analysis of Variance |
MAPCB (CDER) | Manufacturing Assessment & Pre-Approval Compliance Branch (CDER) |
MAPP | Manual of Policy and Procedures |
MARCS | Mission Accomplishment and Regulatory Compliance Services System (ORA) |
MARS | Mobile Automated Regulatory Services (ORA) |
MATS | Management Assignment Tracking System |
MATTB (CBER) | Manufacturers Assistance and Technical Training Branch (CBER) |
MAUDE | Manufacturer and User Facility Device Experience Database (CDRH) |
MAV | maximum allowable variation |
MB (CFSAN) | Microanalytical Evaluations Branch (CFSAN) |
MBB | Master Black Belt |
MBBS | Bachelor of Medicine and Bachelor of Surgery |
MBC | Minimum Biocidal Concentration |
MBP | Microprecipitated Bulk Powder |
MCA | Medicines Control Agency (UK – obsolete term; see MHRA) |
MCA | Medicines Control Agency (part of MHRA) |
mCAFT | Modified Canadian Aerobic Fitness Test |
MCB | Master Cell Bank |
MCE | Mixed Cellulose Esters |
MCI | Mild Cognitive Impairment |
MCL | Medial Collateral Ligament |
MCM | medical countermeasure |
MCMi | Medical Countermeasures initiative |
MCO | managed care organization |
MCTA | Microbial Content Test Agar (aka TSALT) |
MD | Muscular Dystrophy |
MDA | Medical Device Amendments of 1976 |
MDA | Medical Devices Agency (UK) |
MDB | Medical Devices Bureau (Canada) |
MDB (CFSAN) | Methods Development Branch (CFSAN) |
MDC | Minimum Detectable Concentration |
MDC | Minimum Detectable Change |
MDD | Medical Device Directive |
MDD | Major Depressive Disorder |
MDD | Microbiological Data Deviation |
MDD | maximum daily dose |
MDD | Medical Devices Directives (EU) |
MDDI | Medical Device Diagnostic Industry (Magazine) |
MDDRP | Medical Device Dispute Resolution Panel |
MDEL | Medical Device Establishment License |
MDI | Metered Dose Inhaler |
MDII | Medical Device Innovation Initiative |
MDL | model number (ORA AofC code) |
MDMA | Medical Device Manufacturers Association |
MDP | Medical Devices Program (Canada) |
MDR | Medical Device Regulation |
MDR | Multiple Drug Resistance |
MDR | Multidrug Resistant |
MDR | medical device reporting |
MDRO | Multiple Drug Resistant Organism |
MDSAP | Medical Device Single Audit Program |
MDT | Mean Down Time |
MDUFA | Medical Device User Fees Ammendments |
MDUFA | Medical Device User Fee Amendments of 2007 |
MDUFMA | Medical Device User Fee and Modernization Act |
MDUFMA | Medical Device User Fee and Modernization Act of 2002 |
MDUFSA | Medical Device User Fee Stabilization Act of 2005 |
MDV | Medical Device Vigilance |
MEA | Malt Extract Agar |
MedDRA | Medical Dictionary for Regulatory Activities |
MEDEC | Medical Devices Canada |
MEDLARS | Medical Literature Analysis and Retrieval System (NLM) |
MedPAC | Medicare Payment Advisory Commission |
MEDSA | The Medicine Equity and Drug Safety Act of 2000 |
MedSuN | Medical Product Safety Network (CDRH) |
MEDWATCH | FDA Safety Information and Adverse Event Reporting Program |
MEFA | Association of the Danish Pharmaceutical Industry |
MEMO | Medicines Evaluation and Monitoring Organization |
M-Endo | M Endo Agar LES |
MEO | Most Efficient Organization |
METCAL | Metrology and Calibration |
MF | Membrane Filtration |
MFA | Multi-Factor Analysis |
MGB (CFSAN) | Molecular Genetics Branch (CFSAN) |
MGSS | Multi-Generation Support System |
MHLW | Ministry of Health and Labor Welfare Japan |
MHLW | Ministry of Health, Labor and Welfare (Japan) |
mHPC Agar | m-Heterotrophic Plate Count Agar (water testing) |
MHPF | Minority Health Professionals Foundation |
MHRA | Medicines and Healthcare Products Regulatory Agency (UK) |
MHRA | Medicines Healthcare products Regulatory Agency (UK) |
MHSB (CFSAN) | Microbial Hazards Science Branch (CFSAN) |
MHW | Ministry of Health and Welfare (Japan'S Equivalent to The FDA) |
MHz | Megahertz |
MI | Myocardial Infarction |
MIC | Minimum Inhibitory Concentration |
MID | Manufacturer Identifier (CBP) |
MIL STD | Military Standard |
MIP | Management Improvement Plan |
MIS | Management Information System |
MIS | Minimally Invasive Surgery |
MIS (OC) | Management Initiatives Staff (OC) |
MIWG | Mentoring Implementation Working Group |
MJ | Major Amendment |
MKT | Mean Kinetic Temperature |
ML | Medial Lateral |
ML | Maximum Likelihood |
ML | Myelogenous Leukemia |
ML | Malignant Lymphoma |
MLR | Medical Loss Ratio |
MLT | Microbial Limits Test |
MMDR | Medicines and Medical Device Regulation |
MML | Medial Meniscus Ligament |
MMPR | Marijuana for Medicinal Purpose Regulation |
MOA | Memorandum of Agreement |
MOA | Mode of Action |
MOC | Management and Operations Council (FDA) |
MOC | Memorandum of Conference |
MOD | Miscellaneous Obligation Document |
MOD 1 | Module One (Laboratory Facility - CFSAN) |
MOD 2 | Module Two (Laboratory Facility - Cvm) |
MON | Memorandum of Need |
MOU | Memorandum of Understanding |
MPA | Medical Products Agency (Sweden) |
MPA | Multiple Projects (Human Subjects) Assurance |
MPa | Mega Pascals |
MPAB (OC) | Management Programs and Analysis Branch (OC) |
MPC | Medical Policy Council |
MPCA | Modified Plate Count Agar |
MPCC | Medical Policy Coordinating Committee |
MPCC | Medical Policy Coordinating Committee (CDER) |
MPI | Myocardial Perfusion Imaging |
MPN | Most Probable Number |
MPQA | Medical Products Quality Assurance |
MR | Management Review |
MR | Management Representative |
mR | Millirad (Radiation) |
MRA | Medical Research Associate |
MRA | Mutual Recognition Agreement |
MRB | Material Review Board |
MRB | Material Review Board (American National Red Cross) |
MRB (CFSAN) | Methods Research Branch (CFSAN) |
MRC | Managed Review Committee |
MRC | Medical Reserve Corps (U.S. Public Health Service) |
MRI | Magnetic Resonance Imaging |
MRL | Maximum Residue Limit |
MRO | Most Resistant Organism (disinfectancy testing) |
MRP | Manufacturing Resource Planning |
MRRA (CFSAN) | Microbial Research and Risk Assessment Staff (CFSAN) |
MRSA | Methicillin-resistant Staphylococcus aureus |
MRSA | Methicillin Resistant Staphylococcus aureus |
MS | Materials Specification |
MSA | Measurement Systems Analysis |
MSA | Mannitol Salt Agar |
MSAB (CFSAN) | Manufacturing and Storage Adulteration Branch (CFSAN) |
MSB (NCTR) | Mass Spectrometry Branch (NCTR) |
MSDS | Material Safety Data Sheet |
MSDS | Material Safety Data Sheets |
MSE | Measurement System Error |
MSPC | Multivariate Statistical Process Control |
MSS (CVM) | Management Support Staff (CDRH) |
MSSO | Maintenance and Support Services Organization |
MTA | Mail Transport Agent |
MTA | Material Transfer Agreement |
MTBCF | Mean Time Between Critical Failures |
MTBF | Mean Time Between Failures |
MTBM | Mean Time Between Maintenance |
MTR | Mean Time to Repair |
MTTF | Mean Time to Failure |
MTTR | Mean Time to Repair |
MVA | Multi-Variate Analysis |
MVD | Maximum Valid Dilution (LAL Test) |
MVP | Minimally Viable Product |
MW | Molecular Weight |
N | Newtons (Force) |
N.B. | Nota Bene (Note Well) |
N/V | Nausea Vomiting |
NABR | National Association for Biomedical Research |
NADA | New Animal Drug Application |
NAF | Notice of Adverse Findings |
NAFTA | North American Free Trade Agreement |
NAGC | National Association of Government Communicators |
NAHC | National Advisory Health Council |
NAl | No Action Indicated (FDA inspection classification) |
NALBOH | National Association of Local Boards of Health |
NAM | National Agency for Medicines (Finland) |
NARA | National Archives and Records AdMinistration (U.S.) |
NARB | National Advertising Review Board (FTC) |
NARMS | National Antimicrobial Resistance Monitoring System (CDC) |
NAS | National Academy of Sciences (U.S.) |
NB | Notified Body |
NBAC | National Bioethics Advisory Commission |
NBCD | Non Biological Complex Drugs |
NBCS | National Biomedical Computer System (American National Red Cross) |
NBDRC | National Blood Data Resource Center |
NBE | New Biological Entity |
NBII | National Biological Information Infrastructure |
NBS | National Bureau of Standards (Now NIST) |
NC | Non Conformance |
NC | Non-Clinical (Phase, Studies) |
NCA | National Competent Authority |
NCAB | National Cancer Advisory Board |
NCBI | National Center for Biotechnology Information (NCI) |
NCC | National Coordinating Committee |
NCC MERP | National Coordinating Council for Medication Error Reporting and Prevention |
NCCAM | National Center for Complementary and Alternative Medicine (NIH) |
NCCDPHP | National Center for Chronic Disease Prevention and Health Promotion (CDC) |
NCCLS | National Committee for Clinical Laboratory Standards (Now CLIS) |
NCE | New Chemical Entity |
NCHGR | National Center for Human Genome Research (NIH) |
NCHM | National Center for Health Marketing (CDC) |
NCHS | National Center for Health Statistics (CDC) |
NCHSTP | National Center for Hiv, Std, and Tb Prevention (CDC) |
NCI | Non Controlled Items |
NCI | National Cancer Institute (NIH) |
NCID | National Center for Infectious Diseases (CDC) |
NCIE | National Center for Import and Export (USDA) |
NCIE | Notice of Claimed Investigational Exemption (CVM) |
NCIPC | National Center for Injury Prevention and Control (CDC) |
NCL | National Consumers League |
NCMHD | National Center on Minority Health and Health Disparities (NIH) |
NCMR | Non Conforming Material Report |
NCNR | National Center for Nursing Research (NIH) |
NCP | Nonconforming Product |
NCPDP | National Council for Prescription Drug Programs |
NCPHI | National Center for Public Health Informatics (CDC) |
NCPIE | National Council on Patient Information and Education |
NCR | Non Conformance Report |
NCR | Non-Conformance Report |
NCRP | National Council on Radiation Protection and Measurements |
NCRR | National Center for Research Resources (NIH) |
NCS | National Communications System |
NCS | Not Clinically Significant |
NCT | National Clinical Trial |
NCT | Nursing Care Technician |
NCTC | National Collection of Type Cultures (UK) |
NCTR | National Center for Toxicological Research (FDA) |
NCVHS | National Committee on Vital and Health Statistics (DHHS) |
NCVIA | National Childhood Vaccine Injury Act of 1986 |
NCWM | National Conference on Weights and Measures |
NDA | Non Disclosure Agreement |
NDA | New Drug Application |
NDC | Non-Digestible Carbohydrate |
NDC | National Drug Code |
NDE | Non Destructive Evaluation |
NDI | Neck Disability Index |
NDT | Non Destructive Testing |
NEC | Not Elsewhere Classified |
NEMA | National Electrical Manufacturers Association |
NE-NT | Neutralizer Efficacy/Neutralizer Toxicity Test (a.k.a. Method Suitability Test) |
NGO | Non-Governmental Organization |
NHF | National Hemophilia Foundation |
NHGRI | National Human Genome Research Institute (NIH) |
NHIC | National Health Information Center (DHHS) |
NHIN | Nationwide Health Information Network |
NHIS | National Institute of Hygienic Sciences (Japan) |
NHLBI | National Heart, Lung, and Blood Institute (NIH) |
NHRIC | National Health Related Items Code (CDRH) |
NHW | National Health and Welfare Department (Canada'S Equivalent of DHHS) |
NIA | National Institute on Aging (NIH) |
NIAAA | National Institute on Alcohol Abuse and Alcoholism (NIH) |
NIAID | National Institute of Allergy and Infectious Disease (NIH) |
NIAMS | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH) |
NIBIB | National Institute of Biomedical Imaging and Bioengineering (NIH) |
NICCL | National Incident Communications Conference Line |
NICE | National Institute for Health and Clinical Excellence (UK) |
NICHD | National Institute of Child Health and Human Development (NIH) |
NICU | Neonate Intensive Care Unit |
NIDA | National Institute on Drug Abuse (NIH) |
NIDCD | National Institute on Deafness and Other Communication Disorders (NIH) |
NIDCR | National Institute of Dental and Craniofacial Research (NIH) |
NIDDK | National Institute of Diabetes and Digestive and Kidney Diseases (NIH) |
NIDDM | Non-Insulin-Dependent Diabetes Mellitus |
NIDPOE | Notice of Initiation of Disqualification Proceeding and Opportunity to Explain |
NIDR | National Institute of Dental Research (See Nidcr) |
NIDRR | National Institute on Disability and Rehabilitation Research (U.S. Department of Education) |
NIFC | National Interagency Fire Center |
NIGMS | National Institute of General Medical Sciences (NIH) |
NIH | National Institutes of Health |
NIH | National Institutes of Health (DHHS) |
NIH | Not Invented Here |
NIM | No Inspection Made |
NIMH | National Institute of Mental Health (NIH) |
NIMS | National Incident Management System (FEMA) |
NINDS | National Institute of Neurological Disorders and Stroke (NIH) |
NINR | National Institute of Nursing Research (NIH) |
NIOSH | National Institute for Occupational Safety and Health (CDC) |
NIP | National Immunization Program (CDC) |
NIPP | National Infrastructure Protection Plan |
NIRS | Near Infared Spectroscopy |
NIS | National Inpatient Sample |
NISAC | National Infrastructure Simulation and Analysis Center (Department of Homeland Security) |
NIST | National Institute of Standards and Technology (U.S. Department of Commerce) |
NIST | National Institute of Science and Technology |
NIST | National Institute of Standards and Technology |
NLM | National Library of Medicine (NIH) |
NLN | Nordic Council on Medicines |
NLP | No Light Perception |
NLRC | Nicholson Lane Research Center |
NLT | Not Less Than |
Nm | Newton Meters (Torque) |
NMD | National Mammography Database |
NME | New Molecular Entity |
NMPA | National Medical Products Administration (China) |
NMR | Nuclear Magnetic Resonance |
NMT | Not More Than |
NNC | National Notification Center |
NNT | Neonatal Nurse Practitioner |
NOA | Notice of Availability |
NOAEL | No Observable Adverse Effect Level |
NOC | National Operations Center |
NOC | Notice of Compliance (Canada) |
NOD | Notice of Deficiency (Canada) |
NOE | Naturally Occurring Endotoxin |
NoE | Notice of Event |
NON | Notice of Non-Compliance (Canada) |
NOOH | Notice offering An Opportunity for A Hearing |
NORM | Naturally Occurring Radioactive Materials |
NOS | Network Operating System |
NOSB | National Organic Standards Board |
NOV | Notice of Violation Letter |
NP | Nurse Practitioner |
NPG | National Preparedness Goal |
NPI | New Product Introduction |
NPI | National Provided Identifier (CMS) |
NPR | National Performance Review |
NPRM | Notice of Proposed Rulemaking |
NR | Non-Compliance Record |
NR | Response to Not Approvable Letter |
NRB | Noninstitutional Review Board |
NRC | National Research Council |
NRC | Nuclear Regulatory Commission (U.S.) |
NRCC | National Response Coordination Center |
NRCM | National Registry of Certified Microbiologists (aka NRM) |
NREVSS | National Respiratory and Enteric Virus Surveillance System |
NRM | National Registry of Microbiologists (aka NRCM) |
NRP | National Response Plan (Department of Homeland Security) |
NRP-CIS | National Response Plan Catastrophic Incident Supplement |
NRSP | National Research Support Project |
NSAID | Nonsteriodal Anti Inflammatory Drug |
NSC | Nomenclature Standards Committee |
NSTEMI | Non-ST Elevated Myocardial Infarction |
NTI | Narrow-therapeutic index drugs |
NTIA | National Telecommunications and Information AdMinistration (U.S.) |
NTIS | National Technical Information Service |
NTL | National Testing Laboratory (American National Red Cross) |
NV | Nausea Vomiting |
NVA | Non Value Added |
NWB | Non Weight Bearing |
O | Occurrence |
O&M | Operation and Maintenance |
OA | Osteo Arthritis |
OAGS (OC) | Officeof Acquisitions and Grants Services (OC) |
OAI | Official Action Indicated |
OAI Alert | Official Action Indicated Alert (a site has been found to have serious deficiencies) |
OAl | Official Action Indicated |
OAP (CDER) | Office of Antimicrobial Products (CDER) |
OARSA (CFSAN) | Office of Applied Research and Safety Assessment (CFSAN) |
OASDI | Old Age, Survivors, and Disability Insurance |
OASH | Office of The Assistant Secretary for Health (DHHS) |
OASIS | Operational and AdMinistrative System for Import Support (CFSAN) |
OB (CDER) | Office of Biostatistics (CDER) |
OBA | Office of Biotechnology Activities (NIH) |
OBE | Online Booking Engine |
OBE (CBER) | Office of Biostatistics and Epidemiology (CBER) |
OBES (OC) | Office of Business Enterprise Solutions (OC) |
OBFP (OC) | Office of Budget Formulation and Presentation (OC) |
OB-GYN | Obstetrics-Gynecology |
OBI (CDER) | Office of Business Informatics (CDER) |
OBL | Own Brand Labeller |
OBP (CDER) | Office of Biotechnology Products (CDER) |
OBPS (CDER) | Office of Business Process Support (CDER) |
OBRR (CBER) | Office of Blood Research and Review (CBER) |
OC | Immediate Office of The Commissioner (OC) |
OC | Office of Compliance |
OC | Office of The Commissioner (FDA) |
OC (CDER) | Office of Compliance (CDER) |
OC (CDRH) | Office of Compliance (CDRH) |
OC (CFSAN) | Office of Compliance (CFSAN) |
OCAC (CFSAN) | Office of Cosmetics and Colors (CFSAN) |
OCBQ (CBER) | Office of Compliance and Biologics Quality (CBER) |
OCC | Operating Characteristic Curve |
OCC | Object Class Code |
OCC (OC) | Office of The Chief Counsel (OC) |
OCD (CDRH) | Office of The Center Director (CDRH) |
OCIO (OC) | Office of The Chief Information Officer (OC) |
OCM (OC) | Office of Crisis Management (OC) |
OCO (CFSAN) | Office of Constituent Operations (CFSAN) |
OCOD | Office of Communication Outreach and Development (CBER) |
OCOMM (CDER) | Office of Communications (CDER) |
OCP (CDER) | Office of Clinical Pharmacology (CDER) |
OCP (OC) | Office of Combination Products (OC) |
OCPP | Office of Critical Path Programs |
OCS | Office of The Chief Scientist (OC) |
OCTC (OC) | Office of The Counselor to The Commissioner (OC) |
OCTEC (CDER) | Office of Counter-Terrorism and Emergency Coordination (CDER) |
OCTGT (CBER) | Office of Cellular, Tissue and Gene Therapies (CBER) |
OCTMA (CBER) | Office of Communication, Training and Manufacturers Assistance (CBER) |
OD | Office of The Director |
OD | Once Daily |
OD | Orphan Designation |
OD (CBER) | Office of The Director (CBER) |
OD (CDER) | Office of The Center Director (CDER) |
OD (NCTR) | Office of The Director (NCTR) |
ODA | Orphan Drug Act of 1983 |
ODAC | Oncologic Drugs Advisory Committee |
ODE | Office of Drug Evaluation (CDER) |
ODE | Office of Drug Evaluation I through V (NDA review offices) |
ODM | Operational Data Model (CDISC) |
ODSIR (CDER) | Office of Drug Security, Integrity, and Recalls (CDER) |
OE (ORA) | Office of Enforcement (ORA) |
OEA (OC) | Office of External Affairs (OC) |
OECD | Organisation for Economic Co-Operation and Development |
OEEODEM (OC) | Office of Eeo and Diversity Management (OC) |
OEI | Official Establishment Inventory |
OEIO (ORA) | Office of Enforcement and Import Operations (ORA) |
OEL | Occupational Exposure Level |
OEM | Original Equipment Manufacturer |
OEO (OC) | Office of Executive Operations (OC) |
OEP | Office of Emergency Preparedness (PHS) |
OEP | Open Enrollment Period |
OEP (CDER) | Office of Executive Programs (CDER) |
OER (OC) | Office of External Relations (OC) |
OES (OC) | Office of Executive Secretariat (OC) |
OEXA | Office of External Affairs (OC) |
OFACS | Office of Facilities, Acquisitions, and Central Services (FDA) |
OFFAS (OC) | Office of Field FinaNCIal and Acquisitions Services (OC) |
OFM (OC) | Office of FinaNCIal Management (OC) |
OFS (OC) | Office of FinaNCIal Services (OC) |
OFSDO (CFSAN) | Office of Food Safety, Defense and Outreach (CFSAN) |
OGC | Office of The General Counsel (DHHS) |
OGC | Office of the General Counsel |
OGD | Office of Generic Drugs (CDER) |
OGD (CDER) | Office of Generic Drugs (CDER) |
OGE | Office of Government Ethics (U.S.) |
OGROP (OC) | Office of Global Regulatory Operations and Policy (OC) |
OGUD (CDRH) | Obstetrics and Gynecology Devices Branch (CDRH) |
OHCA (OC) | Office of Health and Constituent Affairs (OC) (Formerly Office of Special Health Issues - Oshi) |
OHRMS | Office of Human Resources and Management Services (FDA) |
OIA (OC) | Office of Internal Affairs (OC) |
OIASI (OC) | Office of International Activities and Strategic Initiatives (OC) |
OIE | World Organization for Animal Health |
OIG | Office of Inspector General (DHHS) |
OIM | Office of Information Management (OC) |
OIP (OC) | Office of International Programs (OC) |
OIRA | Office of Information and Regulatory Affairs (Omb) |
OIT (ORA) | Office of Information Technology (ORA) |
OITSS (OC) | Office of Information Technology Shared Services (OC) |
OIVD (CDRH) | Office of In Vitro Diagnostic Device Evaluation and Safety (CDRH) |
OJDB (CDRH) | Orthopedic Joint Devices Branch (CDRH) |
OJT | On-the-Job Training |
OLA (OC) | Office of Legislative Affairs (OC) |
OLE | Object Linking and Embedding (Microsoft) |
OM (OC) | Office of Management (OC) |
OMB | Office of Management and Budget (U.S.) |
OMB (NCTR) | Operations and Maintenance Branch (NCTR) |
OMH (OC) | Office of Minority Health (OC) |
OMO (CDRH) | Office of Management Operations (CDRH) |
OMP | Orphan Medicinal Product |
OMP (CDER) | Office of Medical Policy (CDER) |
OMP (OC) | Office of Management Programs (OC) |
OMPQ (CDER) | Office of Manufacturing and Product Quality (CDER) (Formerly Division of Manufacturing and Product Quality - DMPQ) |
OMPT | Office of Medical Products and Tobacco |
OMRF | Oklahoma Medical Research Foundation |
OMS (CFSAN) | Office of Management Systems (CFSAN) |
ON | Osteo Necrosis |
ONADE (CVM) | Office of New Animal Drug Evaluation (CVM) |
ONC | Office of The National Coordinator for Health Information Technology (DHHS) |
ONCHIT | Office of The National Coordinator for Health Information Technology (DHHS) |
OND (CDER) | Office of New Drugs (CDER) |
ONDQA | Office of New Drug Quality Assessment (CDER) |
ONDQA (CDER) | Office of New Drug Quality Assessment (CDER) |
ONLDS (CFSAN) | Office of Nutrition, Labeling and Dietary Supplements (CFSAN) |
ONP (CDER) | Office of Nonprescription Products (CDER) |
ONPLDS (CFSAN) | Office of Nutritional Products, Labeling and Dietary Supplements (CFSAN) |
OO (CFSAN) | Office of Operations (CFSAN) |
OO (OC) | Offffice of The Ombudsman (OC) |
OO (OC) | Office of Operations (OC) |
OOB | Out of Business |
OODP (CDER) | Office of Oncology Drug Products (CDER) |
OOL | Out of Limit (or Level) (Environmental Monitoring event) |
OON | Out of Network |
OOP | Order of Predominance [In The Ingredients Statement] |
OOP | Out of Pocket |
OOPD | Office of Orphan Products Development |
OOS | Out of Specification |
OOS | Out of Specification (e.g., test results) |
OOT | Out of Tolerance |
OOT | Out of Trend (Environmental Monitoring event) |
OP (OC) | Office of Policy (OC) |
OPA (CDER) | Office of Planning and Analysis (CDER) |
OPA (OC) | Office of Public Affairs (OC) |
OPB (ORA) | Operations and Policy Branch (ORA) |
OPD (OC) | Office of Orphan Products Development (OC) |
OPDFB (CFSAN) | Office of Plants, Dairy Foods and Beverages (CFSAN) |
OPDIV | Operating Division |
OPDP | Office of Prescription Drug Promotion (CDER) (Formerly Division of Drug Marketing, Advertisement and Communications - Ddmac) |
OPF | Official Personnel Folder |
OPFIT (NCTR) | Office of Planning, Finance and Information Technology (NCTR) |
OPHEP | Office of Public Health Emergency Preparedness (Hhs) |
OPI (CDER) | Office of Planning and Informatics (CDER) |
OPL (OC) | Office of Planning (OC) |
OPM | Office of Personnel Management (U.S.) |
OPMAD (CDRH) | Orthopedic Physical Medicine and Anesthesiology Devices Branch (CDRH) |
OPO | Organ Procurement Organization |
OPPL (OC) | Office of Policy, Planning and Legislation (OC) |
OPQ | Office of Pharmaceutical Quality |
OPS | Office of Pharmaceutical Sciences (FDA/CDER) |
OPS (CDER) | Office of Pharmaceutical Science (CDER) |
OQ | Operational Qualification |
OR | Operating Room |
OR | Operational Reliability |
OR (CVM) | Office of Research (CVM) |
ORA | Office of Regulatory Affairs (FDA) |
ORA | Operations Research Analyst |
ORA | FDA Office of Regulatory Affairs |
ORADSS | Office of Regulatory Affairs Reporting, Analysis and Decision Support System |
Orange Book | Approved Drug Products With Therapeutic Equivalence Evaluations |
ORI | Office of Research Integrity (Hhs) |
ORIF | Open Reduction and Internal Fixation |
ORISE | Oak Ridge Institute for Science and Education |
ORM | Operational Risk Management |
ORM (ORA) | Office of Resource Management (ORA) |
ORNL | Oak Ridge National Laboratory |
ORO | FDA Office of Regional Operations |
ORO (ORA) | Office of Regional Operations (ORA) |
ORP (CDER) | Office of Regulatory Policy (CDER) |
ORP (CFSAN) | Office of Regulations and Policy (CFSAN) |
ORPSS (CFSAN) | Office of Regulations, Policy and Social Sciences (CFSAN) |
ORR | Objective Response Rate |
ORS | Orthopedic Research Society |
ORS (CFSAN) | Office of Regulatory Science (CFSAN) |
OS (CDER) | Operations Staff (CDER) |
OSAS | Office of Scientific Analysis and Support (CFSAN) |
OSB | Office Services Branch (CFSAN) |
OSB | Office of Surveillance and Biometrics (CDRH) |
OSC | Office of Surveillance and Compliance (CVM) |
OSCAR | Oracle System for Center Automation and Retrieval |
OSCI | Office of Science (CFSAN) |
OSD | Oral Solid Dosage |
OSD | Oral Solid Dosage Form |
OSDB | Orthopedic Spine Devices Branch (CDRH) |
OSD-HD | Office of The Secretary of Defense for Homeland Defense |
OSE | Office of Surveillance and Epidemiology (CDER) |
OSEL | Office of Science and Engineering Laboratories (CDRH) |
OSG | Office of The Surgeon General (PHS) |
OSHA | Occupational Safety and Health AdMinistration (U.S. Department of Labor) |
OSHA | U.S . Occupational Safety and Health Administration |
OSHC | Office of Science and Health Coordination (OC) |
OSHI | Office of Special Health Issues (OC) |
OSHRC | Occupational Safety and Health Review Commission (U.S.) |
OSI | Office of Scientific Investigation (CDER) (Formerly Division of Scientific Investigation - Dsi) |
OSM | Office of Surface Mining (Department of The Interior) |
OSO | Office of Security Operations (OC) |
OSP | Office of Strategic Programs (CDER) (Formerly Office of Planning and Informatics) |
OSS | Office of Shared Services (OC) |
OST | Office Services Team (CFSAN) |
OSTP | Office of Science and Technology Policy (U.S.) |
OT | Occupational Therapy |
OTC | Over the Counter |
OTCDHFB | Otc Drugs and Health Fraud Branch (CDER) |
OTCOM | Office of Training and Communications (CDER) |
OTR | Office of Testing and Research (CDER) |
OTR | Office of Testing and Research (CDERJOPS/OTR) |
OTRR | Office of Therapeutics Research and Review (CBER) |
OTS | Office of Translational Sciences (CDER) |
OUDLC | Office of Unapproved Drugs and Labeling Compliance (CDER) (Formerly Division of New Drugs and Labeling Compliance - Dndlc) |
OVI | Organic Volatile Impurities |
OVRR | Office of Vaccines Research and Review (CBER) |
OWH | Office of Women'S Health (OC) |
p | P Value (in Hypothesis Testing) |
P & PC | Production and Process Controls |
P Chart | An SPC Chart based on Proportion Defective |
PA | Preventive Action |
PA | Physician Assistant |
PA | Posterio-Anterior |
PAB | Product Adulteration Branch (CFSAN) |
PAb | Polyclonal Antibody |
PAC | Program Assignment Code |
PAC | Post-Approval Changes |
PACA | Perishable Agricultural Commodities Act |
PACMP | Post Approval Change Management Protocol |
PAC-PAC | Guidance on post-approval changes for packaging materials |
PAC-SAS | Guidance on scale-up and post-approval changes for sterile aqueous solutions) |
PACT | Post-Approval Commitment Tracking |
PAER | Preliminary Adverse Event Report Review (CDRH) |
PAG | Project Advisory Group |
PAHO | Pan American Health Organization |
PAI | Pre-Approval Inspection |
PAIS | Public Affairs and Information Staff (ORA) |
PAITS | Pre-Approval Inspection Tracking System |
PAL | Public Affairs Liaison |
PAMS | Post-Approval Monitoring System |
PAO | Public Affairs Office |
PAPR | Powered Air Purifying Respirators |
PAR | Proven Acceptable Range |
PARN | Problem/Action Request Notice |
PARS | Program Activities Review Staff (CDER) |
PART | Program Assessment Rating Tool |
PAS | Premarket Approval Section (CDRH) |
PAS | Public Affairs Specialist |
PAS | Prior Approval Supplement |
PAT | Process Analytical Technology |
PATI | Process Analytical Technology Initiative (CDER) |
PB | Planning Branch (CDRH) |
PBE/IBE | Population Bioequivalence/Individual Bioequivalence |
PBM | Pharmacy Benefit Manager |
PBS | Phosphate Buffered Saline |
PC | Preventive Controls |
PCBE | President'S Council on Bioethics |
PCERT | Preclinical and Clinical Evaluation Review Template (Canada) |
PCI | Percutaneous Coronary Intervention |
PCIP | Pre-existing Condition Insurance Plan |
PCL | Polycapralactone |
PCL | Posterior Cruciate Ligament |
PCL | Poly Capralactone |
PCORI | Patient-Centered Outcomes Research Institute |
PCP | Primary Care Provider |
PCPC | Personal Care Products Council (formerly CTFA) |
PCR | Polymerase Chain Reaction |
PCS | Permanent Change of Station |
PD | Position Description |
PD | Pharmacodynamics |
PD | Parkinsons Disease |
PDA | Parenteral Drug Association |
PDA | Potato Dextrose Agar |
PDCA | Plan-Do-Check-Act |
PDCA | Plan Do Check Act |
PDCS | Policy Development and Coordination Staff (OC) |
PDG | Pharmacopeial Discussion Group (harmonization body) |
PDLB | Pacing, Defibrillator and Leads Branch (CDRH) |
PDO | Protected Designation of Origin |
PDP | Product Development Protocol |
PDP | PrIncipal Display Panel |
PDP | Prescription Drug Plan under Medicare Part D |
PDR | Product Defect Reporting |
PDR | Pan Drug Resistant |
PDUFA | Prespcription Drug User Fee Act |
PDUFA | Prescription Drug User Fee Act of 1992 |
PE | Polyethylene |
PE | Professional Engineer |
PEB | Program Evaluation Branch (ORA) |
PEB | Process Engineering Branch (CFSAN) |
PEC | Primary Engineering Control (from USP <797> - Compounding Pharmacies) |
PEG | Polyethylene Glycol |
PELT | Product Evaluation and Labeling Team (CFSAN) |
PEP | Performance Evaluation Plan |
PER | Pharmaceutical Evaluation Reports (Emea) |
PERI | Pharmaceutical Education and Research Institute |
PES | Hydrophilic Polyethersulfone |
PET | Positron Emission Tomography |
PET | Preservative Effectiveness Test (aka AET, APE) |
PFGE | Pulsed Field Gel Electrophoresis |
PFIPC | Permanent Forum on International Pharmaceutical Crime |
PFL | Professional Flexible Labeling |
PFMEA | Process Failure Modes and Effects Analysis |
PFO | PrIncipal Federal official |
PFS | Piper Fatigue Scale |
PFT | Pulmonary Function Test |
PFW | Prefiltration Water |
PGB | Policy Guidance Branch (CFSAN) |
Ph. Eur. | European Pharmacopoeia |
PHA | Preliminary Hazard Analysis |
PHARMIG | Pharmaceutical Microbiology Interest Group (UK) |
PhD | Piled high and Deep |
PHEMCE | Public Health Emergency Medical Countermeasures Enterprise |
PHI | Protected Health Information |
PHN | Population, Health and Nutrition (Center) |
PHPPO | Public Health Practice Program Office (CDC) |
PHPS | Public Health Prevention Service (CDC) |
PhRMA | Pharmaceutical Research and Manufacturers of America |
PHS | Public Health Service (Act) |
PI | PrIncipal Investigator |
PI | Package Insert (Approved Product Labeling) |
PIB | Program Inspection Branch (CBER) |
PIC/S | Pharmaceutical Inspection Convention; Pharmaceutical Inspection Cooperation Scheme |
PICNIC | Professionals & Citizens Network for Integrated Care |
PIM | Product Information Management |
PIM | Promising Innovative Medicines |
PIP | Personal Importation Policy |
PIP | Peak Inspiratory Pressure |
PIT | Process Improvement Team |
PIV | Personal Identify Verification |
PK | Pharmacokinetics |
PKI | Public Key Infrastructure |
PL | Packaging and Labeling |
PL | Private Label |
PLA | Product License Application (CBER) |
PLA | Product License Application |
PLAIR | Pre-Launch Activities Importation Request |
PLAS | Prior Label Approval System (FSIS) |
PLC | Programmable Logic Controller |
PLGA | Poly Lactic Co Gylolic Acid |
PLI | Pre-License Inspection (CBER) |
PLM | Private Label Manufacturer |
PLS | Product License [Application] Supplement |
PLS | Pending Logging System |
PM | Preventive Maintenance |
PM | Post-Marketing |
PM | Preventative Maintenance |
PMA | Premarket Approval |
PMA | Premarket Application |
PMAA | Premarket Approval Application |
PMAP | Performance Management Appraisal Program |
PMC | Postmarketing Commitment |
PMCC | Project Management Coordinating Committee (CDER) |
PMCF | Post Market Clinical Followup |
PMD | Pharmaceuticals and Medical Devices |
PMDA | Pharmaceutical and Medical Devices Agency (Japan) |
PMF | Public Master File |
PMFList | PMF Email Discussion Group |
PMN | Premarket Notification |
PMN | Device Premarket Notification Number (510K) (ORA AofC Code) |
PMO | Project Management Officer |
PMOA | Primary Mode of Action |
PMP | Project Management Professional |
PMP | Performance Management Program |
PMR | Premarket Report |
PMR | Postmarketing Requirement |
PMRI | Preventive Medicine Research Institute |
PMS | Profile of Mood States |
PMS | Program Management Staff (CDRH) |
PMS | Postmarketing Surveillance |
PMSB | Program Management Services Branch (CDER) |
PMSB | Pharmaceutical and Medical Safety Bureau (Japan) |
PMSC | Pre-Market Surveillance and Compliance (CFSAN) |
PN | Product Name |
PN | Part Number |
PNNL | Pacific Northwest National Laboratory |
PNSU | Probability of Non-Sterile Unit |
PO | Purchase Order |
POB | Program Operations Branch (CBER) |
PODS | Project Oriented Data System |
POF | Probability of Failure |
POP | Plaster of Paris |
POS | Program Operations Staff (CDRH) |
POS | Point-of-Service Plan |
POU | Point of Use |
POWER | Petition Optical Workflow, Exchange and Retrieval (CFSAN'S Farm System) |
PP | Pyrophosphate |
PPA | Poison Prevention Act |
PPAP | Production Part Approval Process |
PPB | Parts per Billion |
PPC | Production and Process Controls |
PPE | Personal Protective Equipment |
PPE | Pay Period Ending |
PPI | Proton Pump Inhibitor |
PPI | Patient Package Insert |
PPM | Planned Preventive Maintenance |
PPM | Program Objective Memorandum |
PPM | Parts per Million |
PPM | Permanent Pacemaker |
PPO | Preferred Provider Organization |
PPP | Point-To-Point Protocol |
PPQ | Process Performance Qualification |
PPS | Policy and Publications Staff (CBER) |
PPTA | Plasma Protein Therapeutics Association |
PPV | Patient Profile Viewer |
PPWMB | Program Planning and Workforce Management Branch (ORA) |
PQ | Performance Qualification |
PQ | Process Qualification |
PQLS | Product Quality Laboratory Staff (CBER) |
PQRI | Product Quality Research Institute |
PR | Product Review Branch (CBER) |
PR | Public Relations |
Pr | Pressure |
PRB | Product Release Branch (CBER) |
PRB | Performance Review Board |
PRLB | Phenol Red Lactose Broth |
PRL-NW | Pacific Regional Laboratory - Northwest (ORA) |
PRL-SW | Pacific Regional Laboratory - Southwest (ORA) |
PRMB | Program and Resources Management Branch (CDER) |
PRN | As Needed |
PRN | Pathology Branch (CFSAN) |
PRRB | Paperwork Reduction and Records Branch (OC) |
PRRC | Person Responsible for Regulatory Compliance |
PRRMS | Paperwork Reduction and Records Management Staff (OC) |
PRS | Policy Research Staff (OC) |
PS | Planning Staff (OC) |
PS | Particle Size |
PSC | Postmarket Strategies Committee |
PSD | Payment Services Division (OC) |
PSDGList | Pharmaceutical Stability Email Discussion Group |
PSI | Pharmaceutical Society of Ireland |
PSI | Patient Safety Indicator |
PSN | Patient Safety News (FDA) |
PSS | Patient Safety Staff (CDRH) |
PSSB | Program Support Services Branch (CFSAN) |
PT | Preferred Term |
PTA | Physical Therapy Assistant |
PTC | Points to Consider |
PTC | Points to Consider (FDA guidance) |
PTE | Patent Term Extension |
PTH | Para Thyroid Hormone |
PTO | Patent and Trademark Office (U.S. Department of Commerce) |
PTS | Product Testing Section (CBER) |
PUD | Peptic Ulcer Disease |
PUFI | Packed Under Federal Inspection |
PV | Process Validation |
p-value | P Value (in Hypothesis Testing) |
PVC | Polyvinyl chloride |
PVD | Peripheral Vascular Disease |
PVD | Posterior Vitreous Detachment |
PVDF | Polyvinylidene Fluoride |
PW | Purified Water |
PWB | Partial Weight Bearing |
PWS | Performance Work Statement |
Q | Quartile |
Q&R | Quality and Reliability |
QA | Quality Assurance |
QAO | Quality Assurance Officer |
QAS | Quality Assurance Staff (CDER) |
QAT | Quality Assurance Team (CBER) |
QAU | Quality Assurance Unit (CFSAN) |
QAU | Quality Assurance Unit |
QbD | Quality By Design |
QbR | Question-Based Review |
QBR | Question-Based Review (generally of CMC sections of ANDAs) |
QC | Quality Control |
QC | Quality Check |
QCP | Quality Control Program |
QFD | Quality Function Deployment |
QHP | Qualified Health Plan |
QID | Four Times A Day |
QM | Quality Manual |
QM | Qualty Management |
QMIS | Quality Management Information System |
QMS | Quality Management System |
QMS | Quality Management Staff (CDER) |
QNS | Quantity Not Sufficient |
QOD | Every Other Day |
QOS | Quality Overall Summary (Of Ctd) |
QP | Qualified Person (Eu) |
QP | Quality Policy |
QP | Qualified Person |
qPCR | Quantitative Polymerase Chain Reaction |
QPM | Quality Policy Manual |
QRB | Quality Review Board |
QRM | Quality Risk Management |
QS | Quality System |
QSAR | Quantitative Structure Activity Relationship |
QSI | Quality Step Increase |
QSIT | Quality System Inspection Technique (CDRH) |
QSM | Quality System Manager |
QSM | Quality System Manual |
QSP | Quality System Procedure |
QSR | Quality System Regulations (FDA) |
QSR | Quality System Representative |
QSR | Quality System Record |
QSR | Quality System Regulation |
QSR | Quality System Report |
QUAD | Quadrilateral Group |
R | Coefficient of Regression |
R Chart | An SPC Chart based on Range |
R&D | Research and Development |
R&R | Repeatability and Reproducibility |
R2A | Reasoner’s Minimal Agar Media for Recovery of Waterborne Microorganisms |
RA | Risk Analysis |
RA | Reliability Analysis |
RA | Regulatory Affairs |
Ra | Roughness Average (Arithmetic) |
RA | Regression Analysis |
RA | Residual Analysis |
RA | Rheumatoid Arthritis |
RA | Regulatory Authority |
RA | Return Authorization |
RA | Radiology Assistant |
RAC | Regulatory Affairs Certification |
RAC | Reviewer Affairs Committee (CDER – disbanded 2000) |
RACI | Responsible Accountable Consulted Informed |
RACT | Risk Assessment Coordination Team (CFSAN) |
RAD | Rapid Applications Development |
RAE | Remedial Action Exemption |
RAM | Reporting and Analysis Module (Ease) |
RAMP | Remedial Action Management Program |
RAPS | Regulatory Affairs Professionals Society |
RAS | Reliability Availability and Servicability |
RBA | Risk Benefit Analysis |
RBD | Risk Based Design |
RC | Root Cause |
RCA | Root Cause Analysis |
RCC | Research Coordinating Committee |
RCF | Regulations Coordination Staff (CFSAN) |
RCR | Risk Control Review |
RCRIM | Regulated Clinical Research Information Management |
RCS | Records Control Schedule |
RCS | Reuter Centrifugal air Sampler (an active air sampler) |
RD | Retinal Detachment |
RDBMS | Relational Database Management System |
RDE | Remote Data Entry |
RDS | Respiratory Distress Syndrome |
REE | Research, Education and Economics (USDA) |
REG NEG | Regulatory Negotiation |
REIS | Regional Economic Information System |
REM | Radiation Equivalent Man |
REMS | Risk Evaluation and Mitigation Strategy |
RESNA | Rehabilitation Engineering & Assistive Technology Society of North America |
RF | Radio Frequency |
RF | Radiofrequency (Ablation) |
RFA | Request for Application |
RFC | Request for Contract |
RFD | Request for Designation |
RFI | Radio-Frequency Interference |
RFI | Request for Information |
RFID | Radio Frequency Identifier |
RFID | Radio Frequency Identification |
RFP | Request for Proposal |
RFQ | Request for Quotation |
RFS | Review Flow System |
RFT | Regular Full Time |
RH | Responsible Head |
RI | Regulatory Intelligence |
RIA | Radioimmunoassay |
RIC | Resident In Charge |
RIF | Reduction-In-Force |
RIM | Regulatory Information Management |
RIMS | Regulatory Information Management Staff |
RIMS | Reference Information Model (Hl7) |
RIS | Regulatory Information Specialist |
RiskMAP | Risk Minimization Action Plan |
RL | Regulatory Letter (FDA Post-Audit Letter) |
RLD | Reference Listed Drug |
RLQ | Right Lower Quadrant |
RLU | Relative Light Unit |
RM | Risk Management |
RM | Reliability and Maintainability |
RM | Registered Microbiologist |
RMA | Returned Material Authorization |
RMAB | Risk Management and Analysis Branch (CDRH) |
RMAT | Regenerative Medicine Advanced Therapy |
RMB | Resource Management Branch (CBER) |
RMCC | Review Management Coordinating Committee (CBER) |
RMF | Risk Management File |
RMM | Rapid Microbiological Method |
RMP | Risk Management Plan |
RMP | Regulatory Management Plan |
RMS | Review Management Staff (CDER) |
RMS | Regulatory Management System |
RMS | Root Mean Square |
RMS-BLA | Regulatory Management System - Biologics License Application |
RMT | Regulations Management Team (CFSAN) |
RN | Registered Nurse |
RO | Reverse Osmosis |
ROA | Read Only Access |
ROC | Receiver Operating Characteristic Curve |
RODAC | Replicate Organism Detection and Counting |
RODS | Real-Time Outbreak & Disease Surveillance System |
RoHS | Restriction of Hazardous Substances |
ROI | Return on Investment |
ROI | Report of Investigation |
ROM | Results Oriented Management |
ROM | Range of Motion |
RPM | Regulatory Project Manager |
RPM | Regulatory Procedures Manual (ORA) |
RPMB | Regulatory Project Management Branch (CBER) |
RPMCC | Regulatory Project Management Coordinating Committee (CDER) |
RPMS | Regulations Policy and Management Staff (OC) |
RPN | Risk Priority Number |
RPO | Regulatory Project Officer |
RPO | Regional Personnel Office |
RPS | Regulatory Policy Staff (CDER) |
RPS | Regulatory Product Submission |
RR | Repeatedly Reactive |
RR | Relative Risk |
RR | Recall Recommendation |
RRCC | Regional Response Coordination Center (FEMA) |
RRS | Resource Reporting System (CBER) |
RRSS | Regulatory Review Support Staff (CDER) |
RSA | Response Surface Analysis |
RSB | Review Support Branch (CDER) |
RSE | Reference Standard Endotoxin |
RSGEMS | Regulations and Special Government Employees Management Staff (CFSAN) |
RSM | Response Surface Method |
RSMB | Reporting Systems Monitoring Branch (CDRH) |
RSNA | Radiological Society of North America |
RSOI | Reception, Staging, Onward Movement, and Integration |
Rsq | R Squared |
RSS | Regulatory Support Staff (CDER) |
RSS | Really Simple Syndication |
RSS | Rdf (Resource Data Framework) Site Summary |
RT | Radiology Technician / Technologist |
RTA | Refusal-To-Accept |
RTD | Real Time Datalogger |
RTE | Ready-To-Eat |
RTF | Refusal to File |
RTFM | Read the Freaking Manual |
RTO | Regional Training Officer |
RTR | Recall Termination Recommendation |
RTR | Refuse to Receive |
RTS | Return to Supplier |
RTV | Return to Vendor |
RTV | Room Temperature Vulcanizing |
RTY | Rolled Throughput Yield |
RUO | Research Use Only |
RUQ | Right Upper Quadrant |
RVIS | Residue Violation Information System |
RVSEB | Rappaport Vassiliadis Salmonella Enrichment Broth |
RWD | Real World Data |
RWE | Real World Evidence |
S | Severity |
S & E | Safety and Effectiveness |
S Chart | An SPC Chart based on Standard Deviation |
S.T.O.P. | Safe Tables Our Priority |
S/N Ratio | Signal to Noise Ratio |
S2D2 | Same Stuff, Different Day |
SA | Supply Agreement |
SAB | Science Advisory Board |
SACS | Scientific Advisors and Consultants Staff (CBER) |
SAE | Serious Adverse Event |
SAER | Standard Adverse Event Report Review (CDRH) |
SAL | Sterility Assurance Level |
SaMD | Software as a Medical Device |
SAP | Statistical Analysis Plan |
SAP | Special Access Program |
SAP | Service Access Point |
SAP | Scientific Advisory Panel |
SAR | Structure-Activity Relationship |
SAS | Surface Air System (an active air sampler) |
SAT | Statistical Applications Team (CFSAN) |
SAT | Site Acceptance Testing |
SBA | Summary Basis of Approval |
SBA | Sheep Blood Agar |
SBC | Summary of Benefits and Coverage |
SBE | State Based Exchange |
SBIA | Small Business and Industry Assistance |
SBLA | Supplemental Biologics License Application |
SBM | State Based Marketplace |
SBNDA | Supplemental New Drug Application |
SBOA | Summary Basis of Approval |
SBRS | Senior Biomedical Research Service |
SC | Supply Chain |
SCAR | Supplier Corrective Action Request |
SCCS | Standard Cubic Centimeter per Second |
SCD | Service Computation Date |
SCDA | Soybean Casein Digest Agar (a.k.a. TSA) |
SCDB | Soybean Casein Digest Broth (a.k.a. TSB) |
SCGD | Special Controls Guidance Documents |
SCM | Supply Chain Management |
SCOGS | Select Committee on Gras Substances |
SCR | System Change Request |
SCRRB | Scientific Compliance and Regulatory Review Branch (ORA) |
SCSO | Supervisory Consumer Safety Officer |
SCUBA | Self-contained Underwater Breathing Apparatus |
SD | Standard Deviation |
SDA | Sabouraud Dextrose Agar |
SDAB | Surveillance and Data Analysis Branch (CDER) |
SDB | Sabouraud Dextrose Broth |
SDM | System Development Methodology |
SDM | Submission Data Model (CDISC) |
SDMS | Scientific Data Management System |
SDN | Screening Deficiency Notice (Canada) |
SDO | Standards Development Organization |
SDS | Safety Data Sheet |
SDS | Submission Data Standards (CDISC) |
SDS | Sodium Dodecyl Sulfate |
SDS-PAGE | Sodium Dodecyl Sulfate Poolyacrylamide Gel Electrophoresis |
SE | Substantially Equivalent |
SE | Standard Error |
SEC | Size Exclusion Chromatography |
SEDS | Shared Establishment Data Service (FHA) |
SEER | Surveillance, Epidemiology, and End Results (Registry of NCI) |
SEM | Scanning Electron Microscope |
SEM | Standard Error of Measurement |
SEM | Scanning Electron Microscopy |
SEND | Standards for Exchange of Nonclinical Data (Consortium) |
SEP | Special Enrollment Period |
SF | Standard Form |
SF | Safety Factor |
SGML | Standard Generalized Markup Language |
SHE | Safety, Health and Environment |
SHOP | Small Business Health Options Program |
SID | Source to Image Distance |
SIG | Strategic Implementation Group |
SIM | Society for Industrial Microbiology |
SIMT | Scientific, Internet/Intranet and Middle Tier (CFSAN) |
SIN | Schedule Identifier Number (ORA AofC Code) |
SIP | Sterilization In Place |
SIP | Steam in Place; or Sterilize in Place; or Sanitize in Place |
SIPOC | Supplier Input Process Output Customer, a methodology to understand the linkage between each |
SIR | Society of International Radiologists |
SIREN | Scientific Information Retrieval and Exchange Network (CFSAN) |
SIS | Streamlined Inspection System (USDA) |
SISPQ | Safety, Identity, Strength, Purity and Quality |
SISTIR | Strategic Information Systems Technical Integration Resources |
SITP | Strategic It Programs (OC) |
SK | Skewness |
SLIP | Serial Line Internet Protocol/Point-To-Point Protocol |
SLO | State Liaison Officer |
SLR | Supplement Labeling Revision |
SM | Starting Material |
SM | Specialist Microbiologist (as per NRM) |
SMA | Sterilizable Microbiological Atrium |
SMART | Submission Management and Review Tracking |
SMART | Specific Measurable Achievable Relevant Time-bound |
SMB | Space Management Branch (OC) |
SMCC | Standards Management Coordinating Committee (CBER) |
SME | Subject Matter Expert |
SME | Significant Medical Event |
SME | Society of Manufacturing Engineers |
SMEPAC | Standardized Measurement of Particulate Airborne Contamination |
SMEWW | Standard Methods for the Examination of Water & Wastewater |
SMF | Site Master File |
SMG | Staff Manual Guide |
SMO | Site Management Organization |
SMPS | Standards Management Program Staff (CDRH) |
SMS | Safety Management Staff (CFSAN) |
SMS | Standards Management Staff (CDRH) |
SMSB (CFSAN) | Spectroscopy and Mass Spectrometry Branch (CFSAN) |
SMT | Statistical Methodology Team (CFSAN) |
SMTC | PQRI Science Management Technical Committee |
SN Ratio | Signal to Noise Ratio |
SN/AEMS | Special Nutritional Adverse Events Monitoring System |
SNAFU | Situation Normal – All Fouled Up |
sNDA | Supplemental New Drug Application |
SNF | Skilled Nursing Facility |
SNL | Sandia National Laboratories |
SNOMED-RT | Systematized Nomenclature of Medicine Reference Terminology |
SNP | Single Nucleotide Polymorphism (DNA sequencing) |
SNS | Strategic National Stockpile (CDC) |
SOAB | Systems and Office Automation Branch (OC) |
SOB | Shortness of Breath |
SOC | System Organ Class |
SOCRA | Society of Clinical Research Associates |
SOL | System Operating Limits |
SOM | Sensitivity of Method |
SOP | Standard Operating Procedure |
SoPA | Submission of Portion of Application |
SOPP | Standard Operating Procedures and Policies |
SORN | System of Records Notice |
SPA | Special Protocol Assessment |
SPC | Statistical Process Control |
SPC | Summary of Product Characteristics (Emea) |
SPC | Standard Plate Count |
SPCS | Safety Policy and Communications Staff (CDER) |
SPE | State Partnership Exchange |
Spec | Specification |
SPECT | Single Photon Emission Computerized Tomography |
SPECT | Single-Photon Emission Computed Tomography |
SPIE | International Society for Optical Engineering |
SPL | Structured Product Labeling |
SPL | Structured Process Labeling |
SPLAT | Structured Product Labeling Advisory Team |
SPLEIP | Structured Product Labeling Interagency Executive Panel |
SPM | State Partnership Marketplace |
SPOTS | Special Products On-Line Tracking System (CDER) |
SPP | Specialty Pharmacy Provider |
SPR | System Problem Report |
SPS | Science and Policy Staff (CFSAN) |
SPS | Sanitary and Phytosanitary |
SPV | Sterile process validation |
SQ | Subcutaneous |
SQA | Society of Quality Assurance |
SQA | Software Quality Assurance |
SQA | Supplier Quality Agreement |
SQC | Statistical Quality Control |
SQE | Supplier Quality Engineer |
SQF | Safe Quality Food |
SQL | Structured Query Language |
SR | Significant Risk |
SRAS | Secure Remote Access Service |
SRCS | Division of Surveillance, Research, and Communication Support (CDER) |
SRD | System Requirements Document |
SRD | Single Rising Dose |
SRD | Significant Risk Device |
SRE | Society of Reliability Engineers |
SRMs | Specified Risk Materials |
SRS | Science and Research Staff (CDER) |
SRS | System Requirements Specification |
SRS | Substance Registration System |
SRS | Spontaneous Reporting System |
SRS | Simple Random Sample |
SS | Sum of Squares |
SS | Stainless Steel |
SSA | Sector-Specific AgeNCIes |
SSA | System Safety Assessment |
SSA | Salmonella/Shigella Agar |
SSAFE | Safe Supply for Affordable Food Everywhere, Inc. |
SSAST | Senior Science Advisor'S Staff (CFSAN) |
SSB | Systems Support Branch (CDRH) |
SSC | Systems Steering Committee (CBER) |
SSC | Special Search Category |
SSCT | Swedish Society for Clinical Trials |
SSD | Site-specific Stability Data |
SSDI | Social Security Disability Income |
SSE | Summary of Safety and Effectiveness |
SSED | Summary of Safety and Effectiveness Data |
SSI | Supplemental Security Income |
SSM | Skin Surface Microscopy |
SSOP | Sanitation Standard Operating Procedures |
SSP | Sector-Specific Plan |
SSRCR | Suggested State Regulations for Control of Radiation |
SSSI | Skin and Skin Structure Infection |
STA | Special Temporary Authority |
STAMP | Systematic Technology Assessment of Medical Products (CDRH) |
STARS | Submission Tracking and Reporting System |
STB | State Training Branch (ORA) |
STCD | Sterile Connecting Device |
STED | Summary Technical Document |
STEM | Scanning Transmission Electron Microscope |
STEMI | ST Elevated Myocardial Infarction |
STN | Submission Tracking Number |
STOP | Safe Tables Our Priority |
STS | Standards and Testing Staff (CBER) |
STT | Short Term Tests |
SUB | Single Use Bioreactor |
SUDs | Single Use Devices |
SUPAC | Scale Up and Post-Approval Changes |
SUPAC | Guidance on Scale-up and Post Approval Changes |
SUPAC-IR | Scale-Up and Postapproval Changes--Immediate Release |
SUPAC-IR/-MR/-TDS/-SS | Guidances on scale-up and post-approval changes for immediate release products, modified release products, transdermal systems, and semi-solids |
SUPAC-MR | Scale-Up and Postapproval Changes--Modified Release |
SUPAC-SS | Scale-Up and Postapproval Changes--Nonsterile Solid |
SUSAR | Suspected Unexpected Serious Adverse Reaction |
SV&V | Software Verification and Validation |
SVP | Small-Volume Parenteral |
SVP | Small Volume Parenteral |
SW | Software |
SW | Soften Water |
SWAG | Scientific Wild Ass Guess |
SWDB | Software and Web Development Staff (CDRH) |
SWFI | Sterile Water for Injection |
T&A | Time and Attendance |
T/PT | Traceability/Product Tracing |
TA | Tentative Approval |
TA | Temporary Abeyance |
TAB | Technical Assistance Branch (CDRH) |
TAM | Total Addressable Market |
TAMC | Total Aerobic Microbial Count |
TANSTAAFL | There Ain’t No Such Thing As A Free Lunch |
TARFU | Things Are Really Fouled Up |
TAS | Technology Advancement Staff (NCTR) |
TAVR | Transcatheter Aortic Valve Replacement |
TBD | To Be Determined |
TBF | Time Between Failures |
TBP | Therapeutic Biologic Product |
TBSB | Therapeutics and Blood Safety Branch (CBER) |
TBT | Technical Barriers to Trade |
TC | Technical Committee |
TCO | Total Cost of Ownership |
TCP | Tri Calcium Phosphate |
TCS | Temporary Change of Station |
TCT | Temperature Cycle Test |
TDD | Telecommunications Device for The Deaf |
TDDS | Transdermal Drug Delivery System |
TE | Therapeutic Equivalence |
TEB | Therapeutics Evaluation Branch (CBER) |
TEM | Transmission Electron Microscope |
TERMIS | Tissue Engineering and Regenerative Medicine International Society |
TESS | Treatment Emergent Signs and Symptoms |
TESS | Toxic Exposure Surveillance System |
TFF | Tangential Flow Filtration |
TFRB | Therapeutic Facilities Review Branch (CDER) |
TGA | Therapeutic Goods AdMinistration Australia |
TGA | Thermo-Gravimetry Analysis |
TGA | Therapeutic Goods AdMinistration (Australia) |
THA | Total Hip Arthroplasty |
TI | Tolerable Intake |
TIA | Transient Ischemic Attack |
TIACC | Therapeutic Inequivalence Action Coordinating Committee |
TID | Three Times A Day |
TJA | Tomato Juice Agar |
TJR | Total Joint Replacement |
TKA | Total Knee Arthroplasty |
TKR | Total Knee Replacement |
TMJ | Tempo Mandibular Joint |
TMO | Trial Management Organization |
TMV | Test Method Validation |
TNTC | Too Numerous to Count |
TO | Table of Oganization |
TOA | Total Obligation Authority |
TOC | Theory of Constraints |
TOC | Total Organic Carbon |
TOI | Trial Outcome Index |
TOPRA | The Organisation for Professionals In Regulatory Affairs |
TOR | Threshold of Regulation |
TPA | Third Party Administrator |
TPCC | Therapeutic Products Classification Committee (Canada) |
TPDS | Training and Professional Development Staff (CBER) |
TPLC | Total Product Life Cycle |
TPM | Total Preventive Maintenance |
TPM | Total Productive Maintenance |
TPP | Target Product Profile |
TPS | Toyota Production System |
TQM | Total Quality Management |
TR | Technical Report |
TRAC | Tolerance Reassessment Advisory Committee (Epa) |
TRB | Technical Review Board |
TRIMS | Tissue Residue Information System |
TS | Tensile Strength |
TS | Technical Specification |
TS | Test Solution (as in USP’s “Saline TS”) |
TSA | Trypticase Soy Agar (a.k.a. SCDA) |
TSALT | Trypticase Soy Agar with Lecithin and Tween (aka MCTA) |
TSB | Trypticase Soy Broth (a.k.a. SCDB) |
TSCSB | Telecommunications and Scientific Computer Support Branch (CFSAN) |
TSE | Transmissible Spongiform Encephalopathies |
TSOP | Temperature Standard Operating Procedures |
TSSRC | Toxicology Study Selection and Review Committee (FDA-Niehs) |
TSSS | Technology Support Services Staff (CDER) |
TTF | Time to Fail |
TTT | Total Time in Test |
TTT | Train the Trainer |
Turbo EIR | Turbo Establishment Inspection Report (ORA) |
TVAC | Total Viable Aerobic Count |
TVBB | Tumor Vaccines and Biotechnology Branch (CBER) |
TVC | Total Viable Count |
TWG | Technical Working Group |
TYMC | Total Yeast and Mold Count |
UA | Urinalysis |
UADE | Unanticipated Adverse Device Event |
UAI | Use As Is |
UCL | Upper Control Limit |
UCR | Usual, Customary and Reasonable Charges |
UCUM | Unified Codes for Units of Measure (Regenstrief Institute) |
UDI | Unique Device Identification |
UDID | Unique Device Identification Database |
UF | Ultrafiltration |
UFC | Unacceptable to Foreign Country (ORA AofC Code) |
UFMS | Unified FinaNCIal Management System |
UHMWPE | Ultra High Molecular Weight Polyethylene |
UII | Unique Ingredient Identifier |
UIN | Unique Identification Number |
UL | Underwriters Laboratories |
ULD | Upper Limb Disorder |
ULDB | Urology and Lithotripsy Devices Branch (CDRH) |
ULPA | Ultra-Low Penetration (or Particulate) Air |
UM | User Manual |
UMDNS | Universal Medical Device Nomenclature System |
UN | Unacceptable |
UN | United Nations |
UNL | Upper Limit of Normal |
UPC | Universal Product Code |
UPS | Uninterrupted Power Supply |
URI | Upper Respiratory Infection |
URL | Uniform Resource Locator |
URS | User Requirement Specification |
USAID | United States Agency for International Development |
USAMRIID | U.S. Army Medical Research Institute for Infectious Diseases |
USAN | United States Adopted Name |
USC | United States Code |
USCA | U.S. Code Annotated |
USDA | United States Department of Agriculture |
USDA | U.S. Department of Agriculture |
USDA | US Department of Agriculture |
USHIK | United States Health Information Knowledge Base |
USIA | United States Information Agency |
USITC | United States International Trade Commission |
USL | Upper Specification Limit |
USP | United States Pharmocopoeia |
USP | United States Pharmacopeia |
USP-NF | United States Pharmacopeia-National Formulary |
USPTO | United States Patent and Trademark Office (U.S. Department of Commerce) |
USPTO | US Patents and Trademarks Office |
USTR | United States Trade Representative |
USUHS | Uniformed Services University of The Health Sciences |
UTI | Urinary Tract Infection |
UTS | Ultimate Tensile Strength |
UV | Ultra Violet |
UV | Ultra-Violet |
UVA | Ultra Violet A |
UVB | Ultra Violet B |
V&V | Verification and Validation |
V/V | Verification/Validation |
VA | Value Added |
VA | Veterans Administration |
VA | Value Analysis |
VAI | Voluntary Action Indicated |
VAl | Voluntary Action Indicated |
VAl | Voluntary Action Indicated (FDA inspection classification) |
VAP | Ventilator Associated Pneumonia |
VAR | Value at Risk |
VAS | Visual Analog Scale |
VATS | Vacancy Announcement Tracking System (PHS) |
VBNC | Viable But Not Culturable |
VCAR | Vendor Corrective Action Request |
VCD | Vascular Closure Device |
VCOOL | Voluntary Country-Of-Origin Labeling |
VDB | Virology Devices Branch (CDRH) |
VE | Value Engineering |
VEDB | Vitreal and Extraocular Devices Branch (CDRH) |
VF | Ventricular Fibrillation |
VHP | Vaporized Hydrogen Peroxide (a.k.a. HPV) |
VHPH | Vapor phase Hydrogen Peroxide |
VI | Vascular Interventional |
VIR | Vascular & Interventional Radiology |
VISB | Visual Information Services Branch (OC) |
VL | Visual Limit |
VMP | Validation Master Plan |
VOC | Voice of The Customer |
VOE | Verification of Effectiveness |
VOP | Voice of The Process |
VR | Virtual Reality |
VRBPAC | Vaccines and Related Biological Products Advisory Committee (CBER) |
VRSA | Vancomycin Resistant Staphylococcus aureus |
VS | Visiting Scientist |
VSA | Value Stream Analysis |
VSM | Value Stream Map |
VSS | Vital Signs are Stable |
VT | Ventricular Tachycardia |
WBAT | Weight Bearing As Tolerated |
WCRIM | World Class Regulatory Information Management |
WDS | Wavelength Dispersive X-Ray Spectroscopy |
WDX | Wavelength Dispersive X-Ray Spectroscopy |
WFI | Water for Injection |
WG | Working Group |
WHO | World Health Organization |
WI | Work Instructions |
WIP | Work in Process |
WL | Warning Letter |
WMS | Warehouse Management System |
wrt | With Respect To |
WSHSC | Water Soluble, Heat Stable Chemicals |
WTO | World Trade Organization |
X bar R Chart | An SPC Chart based on Averages of Measurements and Range |
XDR | Extensively Drug Resistant |
XLD Agar | Xylose Lysine Deoxycholate Agar |
XML | Extensible Markup Language |
XPS | X-ray Photoelectron Spectroscopy |
XRD | X-Ray Diffraction |
Y | Yield |
YMM | Yeast and Mold Medium |
YP | Yield Point |
ZOI | Zone of Inhibition |
Acronym Suggestion Form
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