| Regulatory
Acronyms and Abbreviations |
| AAAS
|
American
Association for the Advancement of Science |
| AABB |
American Association of Blood Banks |
| AADA |
Abbreviated
Antibiotic Drug Application |
| AAPS
|
American
Association of Pharmaceutical Scientists |
| ACE |
Adverse
Clinical Event |
| ACIL |
American Council of Independent companies |
| ACP
|
Associates
of Clinical Pharmacology |
| ACT
|
Applied
Clinical Trials |
| ADAA |
Animal
Drug Availability Act |
| ADE |
Adverse Drug Event |
| ADI
|
Acceptable
Daily Intake |
| ADME
|
Absorption,
Distribution, Metabolism and Excretion |
| ADR |
Adverse
Drug Reaction |
| ADRS
|
Adverse
Drug Reporting System |
| AERS |
Adverse
Events Reporting System |
| AF |
Administrative
FIle |
| AIM
|
Active
Ingredient Manufacturer |
| AMA |
Agricultural Marketing Act of 1946 |
| AMA-DE |
AMA Drug Evaluations |
| 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 |
| ANSI |
American
National Standards Institute |
| AOAC
|
Association
of Official Analytical Chemists |
| APHIS |
Animal and Plant Health Inspection Service |
| AQL |
Acceptable
Quality Level |
| ASCO
|
American
Society for Clinical Oncology |
| ASCPT
|
American
Society for Clinical Pharmacology and Therapeutics |
| ASM
|
American
Society for Microbiology |
| BCE |
Beneficial
Clinical Event |
| BCP |
Bureau of Consumer Protection |
| BIMO |
Bioresearch
Monitoring |
| BIND |
Biological
Investigational New Drug |
| BLA |
Biologic
License Application |
| BNFs |
Biotechnology Notifications |
| BRMS |
biotechnology
Regulatory Management System |
| BVC |
British
Veterinary Codex |
| BP |
British
Pharmacopoeia |
| CA |
Chemical
Abstracts |
| CA |
Corrective
Action |
| CAs |
competent
authorities (EU) |
| CABS |
Conformity
Assessment Bodies |
| CAPA |
corrective
and preventive action |
| CAPRA
|
Canadian
Association of Pharmaceutical Regulatory Affairs |
| CARS |
Compliance
Achievement Reporting System |
| CAS
|
Chemical
Abstracts Service |
| CCFAC |
Codex Committee on Food Additives
and Contaminants |
| CDC |
Centers for Disease Control and
Prevention |
| CDRH |
Center
for Devices and Radiological Health |
| CFG |
Certificate
for Foreign Governments |
| CFIA |
Canadian Food Inspection Agency |
| CFR |
Code
of Federal Regulations |
| CFSAN |
Center for Food Safety and Applied Nutrition |
| cGMP |
current
Good Manufacturing Practices |
| CH |
Clinical
Hold |
| CI |
clinical
investigator |
| CIB |
Clinical
Investigator's Brochure |
| CIR |
Cosmetic
Ingredient Review |
| CLIA |
Clinical
Laboratory Improvement Amendments of 1988 |
| CMC |
Chemistry
and Manufacturing Controls |
| COE |
Certificate
of Exportability |
| COE |
Code
of Ethics |
| COMSTAT |
Compliance
Status Information System |
| COOL |
country-of-origin labeling |
| CP |
Compliance
Program |
| CRA |
Clinical
Research Assistant |
| CRADA |
Cooperative
Research and Development Agreements |
| CRF |
Case
Report Form |
|
CRO
|
Contract
Research Organization |
| CRS |
Contamination
Response System |
| CS |
Clinically
Significant |
| CSO |
Consumer
Safety Officer |
| CTC |
Clinical
Trial Certificate |
| CTX |
Clinical
Trial Exemption Certification |
| CVM |
Center for Veterinary Medicine |
| DB |
Double-Blind |
| DEEM |
Dietary Exposure Evaluation Model |
| DGI |
Directorate
General for Industry (EU) |
| DHHS |
U.S.
Department of Health and Human Services |
| DHF |
Design
History File |
| DHR |
device
history record |
| DIA |
Drug Information Association |
| DIN |
Drug Identification Number |
| DESI
|
Drug Efficacy Study Implementation |
| DEN |
Drug
Experience Network |
| DMF |
Drug
Master File |
| DMR |
device
master record |
| DOE |
Design
of Experiment |
| DQRS |
Drug
Quality Reporting System |
| DRSL |
Drug
Registration and Listing System |
| DSHEA |
Dietary
Supplement Health and Education Act |
| DUR |
Drug
Utilization Review |
| EA |
Environmental
Assessment |
| EAB |
Ethical
Advisory Board |
| EAR |
Export
Administration Regulations |
| EC |
European
Commission |
| EH&S |
Environmental
Health and Safety |
| ED |
Effective
Dose |
| EDMS |
Electronic
Data Management System |
| EEA |
European
Economic Area |
| EEC |
European Economic Community |
| EFPIA
|
European
Federal of Pharmaceutical Industries Associations |
| EFTA
|
European
Free Trade Association |
| EIA |
Environmental
Impact Assessment |
| EIP |
Emerging
Infection Program |
| EIR |
Establishment
Inspection Report |
| EO |
Executive
Order |
| EOP1 |
End-of-phase 1 |
| EOP2 |
End-of-phase 2 |
| EOS |
End of Study |
| EPA |
Environmental
Protection Agency |
| EPL |
Effective
Patent Life |
| ER
/ ES |
Electronic
Records / Electronic Signatures |
| ESD |
electrostatic
discharge. |
| ETO |
Ethylene
Oxide |
| EUCOMED |
European
Confederation of Medical Devices Associations |
| EUP |
Experimental
Use Permit |
| FAO |
Food and Agriculture Organization |
| FAP |
Food Additive Petition |
| FCN |
food contact notification |
| FCSN |
Food Contact Substance Notifications |
| FDAMA |
Food
and Drug Administration Modernization Act |
| FD&C |
Federal
Food, Drug and Cosmetic Act |
| FDLI |
Food
and Drug Law Institute |
| FIFRA |
Federal Insecticide, Fungicide and Rodenticide
Act |
| FFDCA |
Federal
Food, Drug, and Cosmetic Act |
| FMD |
Field
Management Directives |
| FMEA. |
Failure Modes and Effects Analysis. |
| FMECA.
|
Failure
Modes and Effects Criticality Analysis |
| FOI |
Freedom
of Information |
| FOIA |
Freedom
of Information Act |
| FPL |
Final Printed Labeling |
| FPLA |
Fair
Packaging and Labeling Act |
| FQPA |
Food Quality Protection Act of 1996 |
| FR |
Federal
Register |
| FSANZ |
Food Standards Australia New Zealand |
| FSI |
National
Food Safety Initiative |
| FTA.
|
Fault
Tree Analysis. |
| GAPs |
Good
Agricultural Practices |
| GATT |
General
Agreement on Trades and Tariffs |
| GCP |
Good
Clinical Practices |
| GEMS |
Global Environment Monitoring System |
| GGP |
good
guidance practices |
| GHTF |
Global
Harmonization Task Force |
| GLP |
Good
Laboratory Practices |
| GMDN |
Global
Medical Device Nomenclature |
| GMP |
Good
Manufacturing Practices |
| GRAS |
Generally
Recognized as Safe |
| GRASE |
Generally
Recognized as Safe and Effective |
| GRP |
Good
Review Practice |
| GSFA |
General
Standards for Food Additives |
| HAACP |
Hazard
Analysis and Critical Control Point |
| HAZMAT |
Hazardous
materials handling |
| HDE |
Humanitarian
Device Exemption |
| HUD |
Humanitarian
Use Device |
| IC |
Informed
Consent |
| ICD
|
Informed
Consent Document |
| ICH |
International
Conference of Harmonization |
| IDE |
Investigational
Device Exemption |
| IDSMB
|
Independent
Data Safety Monitoring Board |
| IFE |
Import-For-Export |
| INAD |
Investigational
New Animal Drug |
| IND |
Investigational
New Drug |
| IPO |
initial
public offering |
| IQ |
Installation
Qualification |
| IRB |
Institutional
Review Board |
| ISO |
International Organization for Standardization |
| IVD |
In
Vitro Diagnostics |
| JIFSAN |
Joint Institute of Food Safety and
Applied Nutrition |
| LACF |
Low
Acid Canned Foods |
| LIMS |
company
Information Management Systems |
| MAPP |
Manual
of Policy and Procedures |
| MAV |
maximum allowable variations |
| MDD |
medical
device directives |
| MDMA |
Medical
Device Manufacturers Association |
| MDR |
Medical
Device Reporting |
| MEA |
multilateral environment agreements |
| MFC |
Model Food Code |
| MOA |
Memorandum
of Agreement |
| MON |
Memorandum
of Need |
| MOU |
Memoranda
of Understanding |
| MNVP |
Medically
Necessary Veterinary Product |
| MPRIS
|
Mammography
Program Reporting and Information Systems |
| MQSA |
Mammography
Quality Standards Act |
| MRA |
Mutual
Recognition Agreement |
| NA |
Not
Approvable |
| NADA |
New
Animal Drug Application |
| NAF
|
Notice
of Adverse Findings |
| NAFTA |
North
American Free Trade Agreement |
| NARMS |
National
Antimicrobial Resistance Monitoring System |
| NAS |
New
Active Substance |
| NBs |
notified
bodies (EU) |
| NBS |
National Bureau of Standards |
| NCCLS |
National Committee for Clinical company Standards |
| NCE |
New
Chemical Entity |
| NCIE |
Notice
of Claimed Investigational Exemptions |
| NCS |
Not
Clinically Significant |
| NCTR |
FDA
National Center for Toxicological Research |
| NDA |
New
Drug Application |
| NDE |
New Drug Evaluation |
| NDS |
New
Drug Study |
| NIST |
National Institute for Standards and Technology |
| NF |
National
Formulary |
| NFPA |
National Food Processor Association |
| NLEA |
Nutrition
Labeling and Education Act |
| NME |
New
Molecular ENtity |
| NRC
|
National
Research Council |
| NSE |
not
substantially equivalent |
| NSF
|
National
Science Foundation |
| NSR |
Nonsignificant
Risk |
| NSRD |
non-significant
risk device |
| NTP |
National
Toxicology Program |
| OAI |
Official
Action Indicated |
| OBRR |
Office
of Blood Research and Review |
| OEM
|
original
equipment manufacturer |
| OQ |
Operational Qualification |
| PAITS
|
Pre-Approval
Inspection Tracking System |
| P&PC |
Production
and Process Controls |
| PAR
|
Postapproval
Research |
| PD |
Pharmacodynamics
|
| PDA |
Parenteral
Drug Association |
| PDPs |
Product
Development Protocols |
| PDUFA |
Prescription
Drug User Fee Act of 1992 |
| PhRMA |
Pharmaceutical Research and Manufacturers of America |
| PIFSI |
Produce
and Food Safety Initiative |
| PK |
Pharmacokinetics |
| PMA |
Premarket
Approval |
| PMS
|
Postmarketing
Surveillance |
| PPC |
production
and process controls |
| PQ |
Performance
Qualification |
| PV |
Process
Validation |
| QA |
Quality
Assurance |
| QC |
Quality
Control |
| QSIT |
quality
systems inspections technique |
| QSR |
quality
system regulation |
| RCT |
Randomized
Clinical Trial |
| RPM |
Regulatory
Procedures Manual |
| RTF |
Refusal
to file |
| SAL |
sterility
assurance level |
| SBA |
Summary
Basis of Approval |
| SCGD |
special
controls guidance documents |
| SG |
study
group |
| SMDA |
Safe
Medical Devices Act |
| SOPs |
Standard
Operating Procedures |
| SR |
significant
risk |
| SSE |
Summary
of Safety and Effectiveness |
| SSED |
Summary
of Safety and Effectiveness Data |
| SUD |
single-use
device |
| TEP |
Transatlantic
Economic Partnership |
| TRO |
Temporary
Restraining Order |
| USAN |
United
States Adopted Name |
| USC |
United
States Code |
| 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 |
| V&V |
verification
and validation |
| VV&T
|
validation,
verification, and outsourcing |
