| ACE | Adverse Clinical Event |
| ADAA | Animal Drug Availability Act |
| ADE | Adverse Drug Event |
| ADR | Adverse Drug Reaction |
| AF | Administrative File |
| AMDUCA | Animal Medicinal Drug Use Clarification Act |
| AMG | West Germany Drug Law |
| ANADA | Abbreviated New Animal Drug Application |
| ANDA | Abbreviated New Drug Appplication |
| ANPR | Advance Notice of Proposed Rulemaking |
| AQL | Acceptable Quality Level |
| BCE | Beneficial Clinical Event |
| BIMO | Bioresearch Monitoring |
| BIND | Biological Investigational New Drug |
| BVC | British Veterinary Codex |
| BP | British Pharmacopoeia |
| CA | Chemical Abstracts |
| CAS | Chemical Abstracts Service |
| CFR | Code of Federal Regulations |
| CH | Clinical Hold |
| CIB | Clinical Investigator's Brochure |
| CIR | Cosmetic Ingredient Review |
| CMC | Chemistry and Manufacturing Controls |
| COE | Code of Ethics |
| CP | Compliance Program |
| CRA | Clinical Research Assistant |
| CRADA | Cooperative Research and Development Agreements |
| CRF | Case Report Form |
| CRO | Contract Research Organization |
| CS | Clinically Significant |
| CSO | Consumer Safety Officer |
| CTC | Clinical Trial Certificate |
| CTX | Clinical Trial Exemption Certification |
| DB | Double-Blind |
| DESI | Drug Efficacy Study Implementation |
| DEN | Drug Experience Network |
| DMF | Drug Master File |
| DUR | Drug Utilization Review |
| EA | Environmental Assessment |
| EAB | Ethical Advisory Board |
| EC | European Commission |
| EH&S | Environmental Health and Safety |
| ED | Effective Dose |
| EIR | Establishment Inspection Report |
| EO | Executive Order |
| EOS | End of Study |
| EPA | Environmental Protection Agency |
| EPL | Effective Patent Life |
| ER / ES | Electronic Records / Electronic Signatures |
| EUP | Experimental Use Permit |
| FDAMA | Food and Drug Administration Modernization Act |
| FDLI | Food and Drug Law Institute |
| FFDCA | Federal Food, Drug, and Cosmetic Act |
| FMD | Field Management Directives |
| FOI | Freedom of Information |
| FOIA | Freedom of Information Act |
| FR | Federal Register |
| GATT | General Agreement on Trades and Tariffs |
| GLP | Good Laboratory Practices |
| GMP | Good Manufacturing Practices |
| GRAS | Generally Recognized as Safe |
| GRASE | Generally Recognized as Safe and Effective |
| GRP | Good Review Practice |
| HAACP | Hazard Analysis and Critical Control Point |
| IC | Informed Consent |
| ICH | International Conference of Harmonization |
| IDE | Investigational Device Exemption |
| INAD | Investigational New Animal Drug |
| IND | Investigational New Drug |
| IRB | Institutional Review Board |
| IVD | In Vitro Diagnostics |
| LIMS | Laboratory Information Management Systems |
| MAPP | Manual of Policy and Procedures |
| MDR | Medical Device Reporting |
| MOA | Memorandum of Agreement |
| MON | Memorandum of Need |
| MOU | Memoranda of Understanding |
| MNVP | Medically Necessary Veterinary Product |
| NA | Not Approvable |
| NADA | New Animal Drug Application |
| NAFTA | North American Free Trade Agreement |
| NAS | New Active Substance |
| NCE | New Chemical Entity |
| NCS | Not Clinically Significant |
| NDA | New Drug Application |
| NDS | New Drug Study |
| NF | National Formulary |
| NLEA | Nutrition Labeling and Education Act |
| NME | New Molecular Entity |
| NSR | Nonsignificant Risk |
| OAI | Official Action Indicated |
| PD | Pharmacodynamics |
| PDUFA | Prescription Drug User Fee Act of 1992 |
| PK | Pharmacokinetics |
| PMA | Premarket Approval |
| RCT | Randomized Clinical Trial |
| RPM | Regulatory Procedures Manual |
| RTF | Refusal to file |
| SBA | Summary Basis of Approval |
| SMDA | Safe Medical Devices Act |
| SOPs | Standard Operating Procedures |
| TRO | Temporary Restraining Order |
| USAN | United States Adopted Name |
| USCA | U.S. Code Annotated |
| USP | U.S. Pharmacopeia |
| VAERS | Vaccine Adverse Event Reporting System |
| VAI | Voluntary Action Indicated |
| VFD | Veterinary Feed Directive |
| VMF | Veterinary Master File |
