510(k)	Medical Device Premarket Notification
AADA	Abbreviated Antibiotic Drug Application
AALAC	Asso. For Assessment & Accreditation of Lab. Animal Care Int'l
AAPS	American Association of Pharmaceutical Scientists
Abifarma	Brazilian Pharmaceutical Industry Association
ABPI	Association of British Pharmaceutical Industries
ACCP	American College of Clinical Pharmacology
ACE	Adverse Clinical Event
ACRA	Associate Commissioner for Regulatory Affairs
ACRPI	Association for Clinical Research in the Pharmaceutical Industry (UK)
ACT	Applied Clinical Trials
ADE	Adverse Drug Event, Adverse Drug Effect
ADEC	Australian Drug Evaluation Committee
ADI	Acceptable Daily Intake
ADME	Absorption, Distribution, Metabolism, and Excretion
ADR	Adverse Drug Reaction
ADRAC	Adverse Drug Reaction Advisory Committee (Australia)
AERS	Adverse Event Reporting System (FDA)
AFDO	Association of Food and Drug Officials
AHA	Area health Authority
AHCPR	Agency for Health Care Policy and Research
AICRC	Association of Independent Clinical Research Contractors (UK)
AME	Absorption, Metabolism, Excretion
AMG	Arzneimittelgesetz (German Drug Law)
ANADA	Abbreviated New Animal Drug Application
ANDA	Abbreviated New Drug Application
ANSI	American National Standards Institute
AOAC	Association of Official Analytical Chemists
APHIS	Animal and Plant Health Inspection Service
API	Active Pharmaceutical Ingredients
APIFARM A	Association of the Portuguese Pharmaceutical Industries
AQL	Acceptable Quality Level
ARENA	Applied Research Ethics National Association
ASC	Advertising Standards Council (Canada)
ASCPT	American Society for Clinical Pharmacology and Therapeutics
ASQC	American Society for Quality Control
ATC	Anatomical Therapeutic Chemical (WHO)
ATF	Alcohol, Tobacco, and Firearms (Bureau of)
ATSDR	Agency for Toxic Substances & Disease Registry
AVEG	AIDS Vaccine Evaluation Group
BAPP	British Association of Pharmaceutical Physicians
BARQA	British Association of Research Quality Assurance
BBR	Bureau of Biologicals and Radiopharmaceuticals (Canada)
BCE	Beneficial Clinical Event
BCE	Bureau of Compliance and Enforcement (Canada)
BDS	Bureau of Drug Surveillance (Canada)
BFAD	Bureau of Food and Drugs (Philippines)
BfArM	Germany's Ministry of Health
BGA	Bundesgesundheitsamt (German Public Health Agency)
BGMA	The British Generic Manufacturer's Association
BMA	British Medical Association
BIO	Biotechnology Industry Association
BIRA	The British Institute of Regulatory Affairs
BMI	Body Mass Index
BPA	Bureau of Pharmaceutical Assessment (Canada)
BPC	Bureau of Policy and Coordination (Canada)
CA	Corrective Action
Cas	Competent Authorities (EU)
CANDA	Computer Assisted New Drug Application
CANDS	Computer-Assisted New Drug Submission (Canada)
CAPLA	Computer Assisted Product License Application
CAPLAR	Computer Assisted Product License Agreement Review (FDA)
CAPRA	Canadian Association of Pharmaceutical Regulatory Affairs
CBER	Center for Biologics Evaluation and Research
CCOHTA	Canadian Coordinating Office of Health Technology Assessment
CDC	Centers for Disease Control and Prevention
CDER	Center for Drug Evaluation and Research
CDRH	Center for Devices and Radiological Health
CDSA	Controlled Drugs and Substances Act (Canada)
CE Mark	French for Conformite Europeene
CERFA	Centre d'Etudes et de Reformes de Formulaires Administratifs (FRANCE)
CFR	Code of Federal Regulations
CFSAN	Center for Food Safety and Applied Nutrition
CIB	Clinical Investigator's Brochure
CIOMS	Council for International Organizations of Medical Sciences (WHO)
CM	Chemistry and Manufacturing (Canada)
CMC	Chemistry and Manufacturing Controls
CNS	Central Nervous System
COP	Clinical Operating Plan (Japan)
CPAC	The Central Pharmaceutical Affairs Council (Japan)
CPID	Certified Product Information Document (Canada)
CPMP	Committee for Proprietary Medicinal Products (EMEA)
CPS	Compendium of Pharmaceuticals and Specialists (Canada)
CSD	Committee on Safety of Medicines (UK)
CRA	Clinical Research Associate
CRC	Clinical Research Coordinator
CRO	Contract Research Organization
CSA	Clinical Study Agreement
CSDD	Center for the Study of Drug Development
CSI	Consumer Safety Inspector
CSM	Committee on Safety of Medicines (UK)
CSO	Consumer Safety Officer
CSR	Clinical Study Report
CTA	Clinical Trial Application
CTC	Clinical Trial Certificate
CTFA	Cosmetic,Toiletry and Fragrance Association
CTX	Clinical Trial Exemption
CUF	Commissione Unica del Farmaco (Italy)
CUVP	The Committee for Veterinary Medicinal Products (EMEA)
CVM	Center for Veterinary Medicine
DAL	Defect Action Level
DB	Double-Blind
DCF	Data Clarification Request Form
DD	District Director
DD	Department of Drugs (Swedish Regulatory Agency)
DDMAC	Division of Drug Marketing, Advertising, and Communications
DEA	Drug Enforcement Administration
DEN	Drug Experience Network
DESI	Drug Efficacy Study Implementation
DGD	Now OGD (Formerly CBER's Division of Generic Drugs)
DGFPS	Generic Directorate of Pharmacy of Healthcare Products (SPAIN)
DHHS	Department of Health and Human Services
DHR	Device History Record
DIA	Drug Information Association
DIN	Drug Identification Number (Canada)
DMA	Danish Medicines Agency
DMF	Drug Master File
DMR	Device Master Record
DOE	Division of Enforcement (CDRH)
DPL	Drug Product Licensing (Canada)
DRF	Dose Range Finding (Study)
DRG	Diagnosis Related Groups
DSMB	Data and Safety Monitoring Board
DTC	Direct-to-Consumer
DTP	Direct-to-Patient
EAB	Ethical Advisory Board
EAC	Expert Advisory Committee (Canada)
EC	European Commission
EEA	European Economic Area
EFGCP	European Forum on Good Clinical Practice (Evere, Belgium)
EFPIA	European Federation of Pharmaceutical Industry Associations
EFTA	European Free Trade Association
EIR	Establishment Inspection Report
ELA	Establishment License Application
EMEA	European Medicines Evaluations Agency
EOP1	End-of-Phase1
EOP2	End-of-Phase2
EPA	Environmental Protection Agency
EPAR	European Public Assessment Reports
EPL	Effective Patent Life
EPO	European Patent Office
EPRG	European Pharmacovigilance Research Group
ESRA	European Society of Regulatory Affairs
EUCOMED	European Confederation of Medical Devices Association
Farmindu stria	The Association of the Italian Pharmaceutical Manufacturers
FDC	Food, Drug, & Cosmetic
FDLI	The Food and Drug Law Institute
FOI	Freedom of Information
FOIA	Freedom of Information Act
FPIF	The Finnish Pharmaceutical Industry Association
FR	Federal Register
Fr.P.	The French Pharmacopoeia (Pharmacopee Francaise)
FSIS	Food Safety and Inspection Service
FTC	Federal Trade Commission
FTE	Full Time Equivalent (employee)
FTC	Federal Trade Commission
FTIM	First-time-in-man
FU	Farmacopea Ufficiale, the Italian Pharmacopoeia
FY	Fiscal Year
GAO	General Accounting Office
GATT	General Agreement on Tariffs and Trade
GCP	Good Clinical Practice
GGP	Good Guidance Practices
GLIN	Global Legal Information Network
GLP	Good Laboratory Practice
GMO	Genetically Modified Organisms (EMEA)
GMP	Good Manufacturing Practice
GPMSP	Good Postmarketing Surveillance Practice (Japan)
GRAS	Generally Recognized as Safe (food ingredients)
GSP	Good Statistics Practice
HACCP	Hazard Analysis Critical Control Point (inspection technique)
HDE	Humanitarian Device Exemption
HHS	US Department of Health and Human Services
HIMA	Health Industry Manufacturer's Association
HIV	Human Immunodeficiency Virus
HPB	Health Protection Board (Canada)
IB	Investigator's Brochure
IC	Informed Consent
ICDRA	International Conference of Drug Regulatory Authorities
ICH	International Conference on Harmonization
IDE	Investigational Device Exemption
IDR	Idiosyncratic Drug Reaction
IEC	Independent Ethics Committee
ILAR	Institute for Laboratory Animal Research
IMB	The Irish Medicines Board
IMDA	Irish Medical Device Association
INADA	Investigational New Animal Drug Application
IND	Investigational New Drug (application)
INDC	Investigational New Drug Committee
INFARME D	Instituto Nacional da Farmacia e do Medicamento (Portugal)
INN	International Approved Names for Pharmacopoeial Substances
IPRO	Independent Pharmaceutical Research Organization
IPU	Irish Pharmaceutical Union
IRB	Institutional Review Board
IRC	Institutes Review Committee
IRD	International Registration Document
ISE	Integrated Summary of Efficacy
ISO	International Standards Organization
ISPE	International Society of Pharmaceutical Engineers
ITT	Intent-to-Treat
IVD	In Vitro Device, In Vitro Diagnostics
JAN	Japanese Adopted Names
JPMA	Japan Pharmaceutical Manufacturer's Association
KS	Kaposi's Sarcoma
LACF	Low Acid Canned Food
LCDC	Laboratory Centre for Disease Control (Canada)
LOA	Letter of Agreement
LS	Labelling Standard (Canada)
MA	Marketing Authorization
MAD	Multiple Ascending Dose
MAH	Marketing Authorisation Holder (EC)
MAPP	Manual of Policy and Procedure
MCA	Medicines Control Agency (UK)
MDA	Medical Devices Agency (UK)
MDB	Medical Devices Bureau (Canada)
MDDs	Medical Device Directives
MDI	Metered Dose Inhaler
MDMA	Medical Device Manufacturers Association
MDP	Medical Devices Program (Canada)
MDR	Medical Device Reporting
MDV	Medical Device Vigilance
MDD	Medical Devices Directives (EU)
MEDEC	Medical Devices Canada
MEFA	The Association of the Danish Pharmaceutical Industry
MEMO	Medicines Evaluation and Monitoring Organization
MHW	Ministry of Health and Welfare (Japan's Drug Regulatoy Agency)
MLD	Minimal Lethal Dose
MOU	Memorandum of Understanding
MPA	Medical Products Agency (Sweden)
MPA	Multiple Project Assurance
MRA	Mutual Recognition Agreements
MRD	Multiple Rising Dose
MRFG	Mutual Recognition Facilitating Group
MRI	Magnetic Resonance Imaging
MQSA	Mammography Quality Standards Act of 1992
MTD	Maximum Tolerated Dose
NADA	New Animal Drug Application
NAF	Notice of Adverse Findings (FDA Post-audit Letter)
NAFTA	North American Free Trade Agreement
NAI	No Action Indicated (favorable FDA post- inspection classification)
NAM	National Agency for Medicines (Finland)
NBs	Notified Bodies (EU)
NCBI	National Center for Biotechnology Information
NCCLS	National Committee of Clinical Laboratory Standards
NCE	New Chemical Entity
NCHS	National Center for Health Statistics (in CDC)
NCI	National Cancer Institute
NCPIE	National Council on Patient Information and Education
NCTR	National Center for Toxicological Research
NDA	New Drug Application
NDAB	National Drugs Advisory Board (Ireland)
NDAC	Nonprescription Drug Advisory Committee
NDS	New Drug Submission (Canada)
NEFARMA	The Dutch Association of the Innovative Pharmaceutical Industry
NHIS	National Institute of Hygienic Sciences (Japan)
NIAID	National Institute of Allergies and Infectious Diseases (NIH)
NIH	National Institutes of Health
NINDS	National Institute of Neurological Disorders & Stroke (NIH)
NLEA	Nutrition Labeling and Education Act of 1990
NLN	Nordic Council on Medicines
NME	New Molecular Entity
NMI	Non-medicinal Ingredients
NMFS	National Marine Fisheries Service
NOC	Notice of Compliance (Canada)
NOD	Notice of Deficiency (Canada)
NOMI	Federation of Norwegian Pharmaceutical Manufacturers
NON	Notice of Non-Compliance (Canada)
NPA	The National Pharmaceutical Association (UK)
NRB	Noninstitutional Review Board
NRC	Nuclear Regulatory Commission
NSAID	Nonsteroidal Anti-inflammatory Drug
NTA	Notice to Applicants (EC)
NTCR	National Center for Toxicological Research
OAI	Official Action Indicated (Serious FDA post-inspection Classification)
OASIS	Operational and Administrative System for Import Support
OC	Office of the Commissioner
OCA	Office of Consumer Affairs
OCI	Office of Criminal Investigation
ODE	Office of Device Evaluation (CDRH)
ODE	Office of Drug Evaluation
OEF	Greece's National Drug Organisation
OEI	Official Establishment Inventory
OGD	Office of Generic Drugs
OHA	Office of Health Affairs
OLA	Office of Legislative Affairs
OPA	Office of Public Affairs
OPE	Office of Planning and Evaluation
OPRR	Office of Protection from Research Risks
ORA	Office of Regulatory Affairs
ORI	Office of Research Integrity
ORM	Office of Review Management
OTC	Over-the-Counter (drugs)
PAAB	Pharmaceutical Advertising Advisory Board (Canada)
PAB	Pharmaceutical Affairs Bureau (Japan)
PAG	Project Advisory Group
PAS	Public Affairs Specialist
PCC	Poison Control Center
PCERT	Preclinical and Clinical Evaluation Review Template (Canada)
PD	Pharmacodynamics
PDA	Parenteral Drug Association
PDMA	Prescription Drug Marketing Act
PDP	Product Development Protocols (for medical devices)
PDR	Physician's Desk Reference</