Acronyms

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

PDUFA

Prescription Drug User Fee Act

PER

Pharmaceutical Evaluation Reports (EMEA)

PERI

Pharmaceutical Education & Research Institute

PHRMA

Pharmaceutical Research and Manufacturers Association

PHS

Public Health Service

PI

Package Inserts

PI

Principal Investigator

PK

Pharmacokinetics

PLA

Product License Application (for biologics)

PLF

Product Licensing Framework (Canada)

PMA

Pre-Market Approval (application) (for medical devices)

PMAL

Pharmaceutical Manufacturers Association of Canada

PMPRB

Patented Medicine Prices Review Board (Canada)

PMS

Postmarketing Surveillance

PMSB

Pharmaceutical and Medical Safety Bureau (Japan)

PPMSP

The Procedure for Post Marketing Surveillance Practice (Japan)

PPI

Patient Package Insert

PRIM&R

Public Responsibility in Medicine & Research

PSI

Pharmaceutical Society of Ireland

PSMD

The Postmarketing Surveillance Management Department (Japan)

PSNI

Pharmaceutical Society of Northern Ireland

PSUR

Periodic Safety Update Reports (EMEA)

QA

Quality Assurance

QC

Quality Control

QIS-P

Quality Information Summary Pharmaceuticals (Canada)

QOL

Quality of Life

QSIT

Quality Systems Inspections Technique

RAA

Research Across America

RADAR

Risk Assessment of Drugs- Analysis and Response

RAE

Remedial Action Exemption

RAPS

Regulatory Affairs Professional Society

RFDD

Regional Food and Drug Director

RIAS

Regulatory Impact Analysis Statements (Canada)

RPSGB

Royal Pharmaceutical Society of Geat Britain

RL

Regulatory Letter (FDA post-audit letter)

RMS

Reference Member State (Europe)

RSO

Radiation Safety Officer

RTF

Refusal-to-file

SAD

Single Ascending Dose

SAL

Sterility Assurance Level

SAP

Special Access Program (Canada)

SBA

Summary Basis of Approval

SCT

Society for Clinical Trials

SDN

Screening Deficiency Notice (Canada)

SID

Subject Identification

SLK

Statens Legemiddel Kontroll (Norwegian Medicines Control Authorities)

SMDA

Safe Medical Devices Act

SME

Significant Medical Event

SMOs

Site Management Organizations

SNDA

Supplemental New Drug Application

S/NDS

Supplemental New Drug Submission (Canada)

SNIP

Syndicat National de l'Industrie Pharmaceutique

SOCRA

Society of Clinical Research Associates

SOP

Standard Operating Procedure

SPC

Summary of Product Characteristics (EMEA)

SQA

Society of Quality Assurance

SRD

Single Rising Dose

SSCT

Swedish Society for Clinical Trials

SUD

Sudden Unexpected Death

SUPAC

Scale Up and Post-Approval Changes

SUPAC-IR

Scale Up and Post-Approval Changes- Immediate Release

TGA

Therapeutic Goods Administration (Australia)

TIND

Treatment IND

TK

Toxicokinetics

TPCC

Therapeutic Products Classification Committee (Canada)

TPD

Therapeutic Products Directorate (Canada)

USAN

United States Adopted Name for Pharmacopoeial Substances

USC

United States Code

USDA

United States Department of Agriculture

USP

United States Pharmacopoeia

VAERS

Vaccine Adverse Event Reporting System

WEAC

Winchester Engineering and Analytical Center

WHO

World Health Organization

WL

Warning Letter (FDA post-audit letter)