| 510(k) | Medical Device Premarket Notification |
| AADA | Abbreviated Antibiotic Drug Application |
| ADME | Absorption, Distribution, Metabolism, and Excretion |
| ADR | Adverse Drug Reaction |
| AERS | Adverse Event Reporting System (FDA) |
| ANADA | Abbreviated New Animal Drug Application |
| ANDA | Abbreviated New Drug Application |
| CANDA | Computer-Assisted New Drug Application |
| CAPLA | Computer-Assisted Product License Application |
| CAPLAR | Computer-Assisted Product License Agreement Review (FDA) |
| CBER | Center for Biologics Evaluation and Research |
| CDC | Centers for Disease Control and Prevention |
| CDER | Center for Drug Evaluation and Research |
| CDRH | Center for Devices and Radiological Health |
| CFR | Code of Federal Regulations |
| CFSAN | Center for Food Safety and Applied Nutrition |
| CMC | Chemistry and Manufacturing Controls |
| CNS | Central Nervous System |
| CRA | Clinical Research Associate |
| CRO | Contract Research Organization |
| CSA | Clinical Study Agreement |
| CSR | Clinical Study Report |
| DEA | Drug Enforcement Administration |
| DHHS | Department of Health and Human Services |
| DIA | Drug Information Association |
| DSMB | Data and Safety Monitoring Board |
| DSUR | Development Safety Update Report |
| EAB | Ethical Advisory Board |
| EOP1 | End-of-Phase1 |
| EOP2 | End-of-Phase2 |
| EPA | Environmental Protection Agency |
| EPL | Effective Patent Life |
| F2F | Face-to-Face Meeting |
| FDA | Food and Drug Administration |
| FDCA | Food, Drug, & Cosmetic Act |
| FTC | Federal Trade Commission |
| FTIH | First-time-in-humans |
| GCP | Good Clinical Practice |
| GLP | Good Laboratory Practice |
| GMP | Good Manufacturing Practice |
| GRAS | Generally Recognized as Safe (food ingredients) |
| HDE | Humanitarian Device Exemption |
| IB | Investigator's Brochure |
| ICH | International Conference on Harmonization |
| ICF | Informed Consent Form |
| IDE | Investigational Device Exemption |
| IND | Investigational New Drug |
| INDC | Investigational New Drug Committee |
| IRB | Institutional Review Board |
| IRC | Institutes Review Committee |
| ISO | International Standards Organization |
| IVD | In Vitro Device, In Vitro Diagnostics |
| LOA | Letter of Agreement |
| MAD | Multiple Ascending Dose |
| MDDs | Medical Device Directives |
| MDMA | Medical Device Manufacturers Association |
| MDR | Medical Device Reporting |
| MDV | Medical Device Vigilance |
| NAF | Notice of Adverse Findings (FDA Post-audit Letter) |
| NAI | No Action Indicated (favorable FDA post- inspection classification) |
| NCE | New Chemical Entity |
| NDA | New Drug Application |
| NIAID | National Institute of Allergies and Infectious Diseases (NIH) |
| NIH | National Institutes of Health |
| NINDS | National Institute of Neurological Disorders & Stroke (NIH) |
| NME | New Molecular Entity |
| NMI | Non-medicinal Ingredients |
| PD | Pharmacodynamics |
| PDMA | Prescription Drug Marketing Act |
| PDP | Product Development Protocols (for medical devices) |
| PDR | Physician's Desk Reference |
| PDUFA | Prescription Drug User Fee Act |
| PHRMA | Pharmaceutical Research and Manufacturers Association |
| PHS | Public Health Service |
| PI | Package Inserts |
| PI | Principal Investigator |
| PK | Pharmacokinetics |
| PLA | Product License Application (for biologics) |
| PMA | Pre-Market Approval (application) (for medical devices) |
| PMS | Postmarketing Surveillance |
| QA | Quality Assurance |
| QC | Quality Control |
| QOL | Quality of Life |
| QSIT | Quality Systems Inspections Technique |
| RADAR | Risk Assessment of Drugs- Analysis and Response |
| RFI | Request for Information |
| RTF | Refusal-to-file |
| SAE | Serious Adverse Event |
| SAD | Single Ascending Dose |
| SNDA | Supplemental New Drug Application |
| SOP | Standard Operating Procedure |
| TIND | Treatment IND |
| TK | Toxicokinetics |
| USP | United States Pharmacopoeia |
| WL | Warning Letter (most serious of post-FDA audit letter, demands immediate action within 15 days) |