| regulatory
acronyms
|
| 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 |