Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959
 info@antrix.com

Regulatory Affairs Abbreviations and Acronyms

List

This table contains abbreviations and acronyms that you will encounter throughout your wanderings in the regulatory affairs field.

*Column 1 indicates which of the healthcare manufacturing industries each term is associated with:

B = Biotechnology/Biologics
D = Medical Devices
G = General (all industries)
P = Pharmaceuticals

Industry*
Abbreviation
Term
 
Numeric
 

D

510(k)

Medical Device Premarket Notification

A

AAAS

American Association for the Advancement of Science

AABB

American Association of Blood Banks

AACR

American Association for Cancer Research

P

AADA 

abbreviated antibiotic drug application 

AAFP

American Academy of Family Physicians

AAI

American Academy of Immunologists

AAP

American Association of Pathologists

AAPS

American Association of Pharmaceutical Scientists

ABPI

Association of British Pharmaceutical Industries

ACE

adverse clinical event

ACIL

American Council of Independent Laboratories

ACP

Associates of Clinical Pharmacology

ACRA

Associate Commissioner of Regulatory Affairs

ACRPI

Association for Clinical Research in the Pharmaceutical Industry

ACS

American Chemical Society

P,B

ADE 

adverse drug experience/event 

ADI

acceptable daily intake

P,B

ADME 

absorption, distribution, metabolism, excretion 

ADP

automated data processing

P,B

ADR 

adverse drug reaction 

G,P,B,D

AE 

adverse event 

G,P,B,D

AERS 

adverse event reporting system 

G

AFDO

Association of Food and Drug Officials

AHCPR

Agency for Health Care Policy and Research

AIM

active ingredient manufacturer

G,P,B,D

AIP 

application integrity policy 

abbreviated inspection program

G,P,B,D

ALJ 

administrative law judge 

G

AMA 

American Medical Association

AMA-DE

AMA Drug Evaluations

ANADA

abbreviated new animal drug application

P

ANDA 

abbreviated new drug application 

ANOVA

analysis of variance (statistical test)

G,P,B,D

ANPR 

advance notice of proposed rulemaking 

G

ANSI 

American National Standards Institute

G

AOAC

Association of Official Analytical Chemists

G

APA 

Administrative Procedures Act 

APhA

American Pharmaceutical Association

G

APHIS

Animal and Plant Health Inspection Service (USDA)

P,B

API 

active pharmaceutical ingredient 

AQL

acceptable quality level

ASA

American Statistical Association

ASCO

American Society for Clinical Oncology

ASCPT

American Society for Clinical Pharmacology and Therapeutics

ASM

American Society for Microbiology

G

ASQC 

American Society for Quality Control

P,B

ATF 

Bureau of Alcohol, Tobacco and Firearms (U.S. Dept. of Treasury) 

B

BCE

beneficial clinical event

BID

two times per day

B,D

BiMo 

bioresearch monitoring 

BIND

biological investigational new drug

B

BLA 

biologics license application 

BMB

Bioresearch Monitoring Branch

BMI

body mass index

D

Blue Book 

policies of the Office of Device Evaluation, CDRH (e.g., CDRH's Premarket Notification (510(k)) Refuse to Accept Policy)

P,B

BPC 

bulk pharmaceutical chemical (now called API)

BRB

Biomedical Research Branch

BPM

beats per minute

BSA

body surface area

BVC

British Veterinary Codex

C

CA

Chemical Abstracts

G,P,B,D

CA 

corrective action 

P

 CANDA

computer assisted new drug application

G,P,B,D

CAPA 

corrective and preventive action 

CAPLA

computer assisted product license application

CAPRA

Canadian Association of Pharmaceutical Regulatory Affairs

G,P,B,D

CAs 

competent authorities (EU) 

CAS

Chemical Abstracts Service

CBC

complete blood count

B

CBER 

Center for Biologics Evaluation and Research (FDA) 

CCC

Compliance Coordinating Committee (CDER)

CCRC

certified clinical research coordinator

G

CDC 

Centers for Disease Control and Prevention (DHHS) 

P

CDER 

Center for Drug Evaluation and Research (FDA) 

D

CDRH 

Center for Devices and Radiological Health (FDA) 

G,P,B,D

CE 

certificate of exportability 

continuing education

G

CE Mark 

French for Conformite Europeene 

G

CFR 

Code of Federal Regulations 

CFSAN

Center for Food Safety and Applied Nutrition

G,P,B,D

CGMP, cGMP 

current good manufacturing practice 

G,P,B,D

CGMPs, cGMPs 

current good manufacturing practices 

CH

clinical hold

CIB

clinical investigator's brochure

G

CLIA 

Clinical Laboratory Improvement Amendments 

P,B

CMC 

chemical, manufacturing and control 

CMCCC

Chemistry and Manufacturing Controls Coordinating Committee (CDER)

CME

continuing medical education

CNS

central nervous system

G,P,B,D

COA

certificate of analysis

COSTART

Coding Symbols for Thesaurus of Adverse Reaction Terms

CP

compliance program

G,P,B,D

CPG 

compliance policy guide 

CPMP

Committee for Proprietary Medicinal Products

G,P,B,D

CPSC 

Consumer Product Safety Commission

G,P,B,D

CRA 

clinical research associates 

G,P,D

CRADA

cooperative research and development agreement

CRC

clinical research coordinator

G,P,B,D

CRF 

case report form 

G,P,B,D

CRO 

contract research organization 

CS

civil service

clinically significant

CSDD

Center for the Study of Drug Development

G

CSI

consumer safety inspector

CSM

Committee on Safety of Medicines

G,P,B,D

CSO 

consumer safety officer 

CT

computerized tomography

CTC

clinical trial certificate

CTX

clinical trial exemption certification

CV

curriculum vitae

G

CVM

Center for Veterinary Medicine

D

G

DAL

defect action level

DAS

Drug Abuse Staff

DAWN

drug abuse warning network

DB

double-blind

G

DD

district director

DDIR

Division of Drug Information Resources

P,B

DDMAC 

Division of Drug Marketing, Advertising and Communications (CDER) 

P

DEA 

Drug Enforcement Administration (U.S. Dept. of Justice) 

DEN

drug experience network

DES

Division of Epidemiology and Surveillance

P

DESI 

drug efficacy study implementation 

D

DGI 

Directorate General for Industry (EU) 

D

DHF 

design history file 

G,P,B,D

DHHS 

Department of Health and Human Services 

D

DHR 

device history record 

DIA

Drug Information Association

G,P,B,D

DIOP 

Division of Import Operations and Policy 

P,B

DMB 

Documents Management Branch 

D

DME 

durable medical equipment 

G,P,B,D

DMF 

drug master file

D

DMR 

device master record 

P

DOA 

drugs of abuse 

D

DOE 

Division of Enforcement (Office of Compliance, CDRH) 

G,P,B,D

DOs 

district offices (FDA) 

DRG

diagnosis related groups

DSI

Division of Scientific Investigations

G

DSHEA 

Dietary Supplement Health and Education Act 

D

DSMA 

Division of Small Manufacturers Assistance (CDRH) 

G,P,B,D

DTC 

direct-to-consumer 

DUR

drug utilization review

E

EA

environmental assessment

EAB

ethical advisory board

G

EC 

European Community

European Commission

ECG

electrocardiogram

ED

effective dose

G

EEA 

European Economic Area 

G

EEC 

European Economic Community

EEG

electroencephalogram

EEO

equal employment opportunity

EER

establishment evaluation request

EFPIA

European Federal of Pharmaceutical Industries Associations

EFTA

European Free Trade Association

G,P,B,D

EIR 

establishment inspection report 

G,P,B,D

ELA 

establishment license application 

EO

executive order

EOP1

end-of-phase 1

EOP2

end-of-phase 2

EORTC

European Organization for Research and Treatment of Cancer

EOS

end of study

G

EPA 

Environmental Protection Agency (U.S.)

G

ERISA 

Employee Retirement Income Security Act 

ESS

Executive Secretary and Staff

ETT

exercise tolerance test

G

EU 

European Union 

G,D

EUCOMED 

European Confederation of Medical Devices Associations 

EUP

experimental use permit

F

FACA

Federal Advisory Committee Act 1972

G,P,B,D

FDA 

Food and Drug Administration (DHHS) 

G,P,B,D

FDAMA 

Food and Drug Administration Modernization Act of 1997 

FDA-SRS

spontaneous reporting system of the Food and Drug Administration

G,P,B,D

FDC or FDCA or

FD & C Act 

Federal Food, Drug and Cosmetic Act, also spelled FFD&CA 

FDLI

Food and Drug Law Institute

P

FM 

final monograph 

D

FMEA 

failure mode and effects analysis 

G

FOI 

freedom of information

G

FOIA 

Freedom of Information Act 

FONSI

finding of no significant impact

FPL

final printed labeling

G,P,B,D

FR 

Federal Register

FSIS

Food Safety and Inspection Service

G

FTC 

Federal Trade Commission

FTE

full time equivalent (employee)

FUR

follow up request

G

FY 

fiscal year 

G

G

GAO 

Government Accounting Office

GATT

General Agreement on Tariffs and Trade

GC

General Counsel (FDA)

G,P,B,D

GCP 

good clinical practice 

G,P,B,D

GCPs 

good clinical practices 

P

GDEA 

Generic Drug Enforcement Act 

G,D

GGP 

good guidance practices 

G,P,B,D

GHTF 

global harmonization task force 

GI

gastrointestinal

G,P,B,D

GLP 

good laboratory practice 

G,P,B,D

GLPs 

good laboratory practices 

G,P,B,D

GMP, GMPs 

good manufacturing practices, see, cGMP

G

GPO

Government Printing Office

G,P,B,D

GRAS 

generally recognized as safe 

G,P,B,D

GRASE or GRAS/E

generally recognized as safe and effective

GRP

good review practice

G

GSA 

General Services Administratio

G,P,B,D

 GWQAP

 government wide quality assurance program

H

D

HACCP

hazard analysis critical control point (inspection technique)

G

HCFA 

Health Care Financing Administration (DHHS) 

G

HCO 

health care organizations 

D

HDE 

humanitarian device exemption 

HF

routing code for mail to the Office of the Commissioner of the FDA

HFD

routing code for mail to CDER

HFM

routing code for mail to CBER

HFS

routing code for mail to CFSAN

HFT

routing code for mail to NCTR

HFV

routing code for mail to CVM

HFZ

routing code for mail to CDRH

G,D

HIMA 

Health Industry Manufacturers Association

G

HIPAA 

Health Insurance Portability and Accountability Act 

HMO

health maintenance organization

HPB

Health Protection Branch (Canada's equivalent to the FDA)

G

HPUS 

Homeopathic Pharmacopeia of the United States 

HRG

Health Research Group

HRRC

human research review committee

HRSA

Health Resources and Services Administration

HX

history

I

IACUC

Institutional Animal Care and Use Committee

IARC

International Agency for Research on Cancer

P,B,

IBE 

individual bioequivalence 

IC

informed consent

ICD

informed consent document

G,P,B,D

ICH 

International Conference on Harmonization

ICPEMC

International Commission for Protection Against Mutagens and Carcinogens

ICTH

International Committee on Thrombosis and Hemostases

D

IDE 

investigational device exemption 

IDR

idiosyncratic drug reaction

IDSMB

independent data safety monitoring board

G

IG 

Inspector General 

G,P,B

IM or i.m.

intramuscular 

G

INADA

investigational new animal drug application

P

INDA 

investigational new animal drug application 

P,B

INDs 

investigational new drug applications 

INN

international nonproprietary name

G,P,B,D

IOM 

inspections operations manual 

IPCS

International Program for Chemical Safety

IPRA

international product registration document

IPRO

independent pharmaceutical research organization

G

IQ 

installation qualification 

G,P,B,D

IRB

investigational review board 

G,P,B,D

IRBs

investigational review boards

IRS

identical, related, or similar

G,P,B,D

ISE 

integrated summary of efficacy 

ISPE

International Society for Pharmacoepidemiology

G,P,B,D

ISO 

International Standards Organization

D

ISRO 

independent service and repair organization 

G,P,B,D

ISS 

integrated summary of safety 

G,P,B,D

IV or i.v.

intravenous

D

IVD 

in vitro diagnostic product 

J

JCAH

Joint Commission for the Accreditation of Hospitals

JCAHO

Joint Commission on Accreditation of Health Care Organizations

JCPT

Journal of Clinical Pharmacology and Therapeutics

JCRDD

Journal of Clinical Research and Drug Development

JCRP

Journal of Clinical Research and Pharmacoepidemiology

JPMA

Japan Pharmaceutical Manufacturers Association

L

L & D

labor and delivery

G

LACF

low acid canned food

LD

lethal dose

LD50

lethal dose (50%)

LNC

Labeling and Nomenclature Committee

LOA

letter of agreement

LOC

level of concern

LOCF

last observation carried forward

LRI

lower respiratory infection

D

LS/LS 

life supporting/life sustaining 

LTE

less than effective

M

D

MAP 

management action plan 

G,P,B,D

MAPPs 

Manual of Policies and Procedures 

MBC

minimum bactericidal concentration

G

MCO 

managed care organization 

D

MDA 

Medical Device Amendments 

D

MDDs 

medical device directives 

MDI

metered dose inhaler

D

MDP 

medical devices program (Canada) 

D

MDR 

medical device reporting regulation 

MEDLARS

medical literature analysis and retrieval system

MHW

Ministry of Health and Welfare (Japan's equivalent to the FDA)

MI

myocardial infarction

MIC

minimum inhibitory concentration

G

MOU 

memorandum of understanding 

G

MPA 

multiple project human subjects assurance 

G

MQSA

Mammography Quality Standards Act of 1992

G

MRA 

mutual recognition agreements 

medical research associate

D

MRI 

magnetic resonance imaging 

MTD

maximum tolerated dose

N

NA

not approvable

G

NADA

new animal drug application

NAF

notice of adverse findings

G

NAFTA

North American Free Trade Agreement

G,P,B,D

NAI 

no action indicated 

G

NAS 

National Academy of Sciences 

new active substance

G,P,B,D

NBs 

notified bodies (EU) 

G

NCCLS 

National Committee of Clinical Laboratory Standards

P,B

NCE 

new chemical entity 

G

NCI

National Cancer Institute

NCS

not clinically significant

G

NCTR

National Center for Toxicological Research

P

NDA 

new drug application 

P,B

NDC 

national drug code 

NDS

new drug study

G,P,B,D

NF 

National Formulary (now part of the USP)

NIA

National Institute on Aging

NIAAA

National Institute on Alcohol Abuse and Alcoholism

NIAID

National Institute of Allergy and Infectious Disease

NIAMSD

National Institute of Arthritis and Musculoskeletal and Skin Diseases

NICHD

National Institute of Child Health and Human Development

NIDA

National Institute of Drug Abuse

NIDCD

National Institute of Deafness and other Communication Disorders

NIDDKD

National Institute of Diabetes And Digestive And Kidney Diseases

G,P,B,D

NIDPOE

notice of initiation of disqualification proceedings and opposition to explain

NIDR

National Institute of Dental Research

NIEHS

National Institute of Environmental Health Sciences

NIGMS

National Institute of General Medical Sciences

G

NIH 

National Institutes of Health (DHHS) 

NIMH

National Institute of Mental Health

NINDS

National Institute of Neurological Disorders and Stroke

G

NLEA

Nutrition Labeling and Education Act of 1990

NLM

National Library of Medicine

P,B

NME

new molecular entity

NOEL

no observed effect level

G,P,B,D

NOH 

notice of hearing 

G,P,B,D

NOOH 

notice offering an opportunity for a hearing 

G,P,B,D

NOV 

notice of violations letters 

NRC

National Research Council

Nuclear Regulatory Commission

NSAID

nonsteroidal anti-inflammatory drug

D

NSE 

not substantially equivalent 

NSF

National Science Foundation

D

NSR 

non-significant risk 

P,B

NTI 

narrow therapeutic index 

G

NTIS 

National Technical Information Service (US Dept. of Commerce) 

NTP

National Toxicology Program

O

G,P,B,D

OAI 

official action indicated 

OB-GYN

obstetrics-gynecology

G

D

OC

Office of the Commissioner (FDA General)

Office of Compliance (CDRH) 

G

OCA

Office of Consumer Affairs

G

OCI

Office of Criminal Investigation

OCPB

Office of Clinical Pharmacology and Biopharmaceutics (CDER)

OD

right eye

ODB

observational database

P

ODE 

Office of Drug Evaluation (CDER) 

D

ODE 

Office of Device Evaluation (CDRH) 

OEA

Office of External Affairs

OEB

Office of Epidemiology and Biostatistics (CDER)

OECD

Organization for Economic Cooperation and Development

G

OEI

official establishment inventory

D

OEMs 

original equipment manufacturers 

OGC

Office of the General Counsel

P

OGD 

Office of Generic Drugs (FDA) 

G

OHA

Office of Health Affairs

D

OHIP 

Office of Health and Industry Programs (CDRH) 

G,P,B,D

OIA 

official action indicated 

G,P,B,D

OIG 

Office of the Inspector General 

G

OLA

Office of Legislative Affairs

G

OMB 

Office of Management and Budget

G

OPA

Office of Public Affairs

G

OPE

Office of Planning and Evaluation

G

OQ 

operational qualification

P,B,D

ORA 

Office of Regulatory Affairs (FDA) 

P,B

Orange Book

"Approved Drug Products with Therapeutic Equivalence Evaluations"

OS

left eye

G

OSHA 

Occupational Safety and Health Administration

G,P,B,D

OTC 

over-the-counter 

OTCOM

Office of Training and Communications (CDER)

OTR

Office of Testing and Research (CDER)

OU

both eyes

P

P,B

PAI 

pre-approval inspection

PAITS

pre-approval inspection tracking system

PAR

postapproval research

G

PAS

public affairs specialist

G

PBMs 

pharmacy benefit management companies 

PCC

poison control center

P,B

PCP 

principle display panel 

P,B

PD 

pharmacodynamic 

P

PDMA 

Prescription Drug Marketing Act 

D

PDP 

product development protocols/principal display panel 

P,B

PDUFA 

Prescription Drug User Fee Act

P,B

PE 

pharmacoeconomics 

PhRMA

Pharmaceutical Research and Manufacturers of America

G,P,B,D

PHS 

Public Health Service (DHHS) 

G,P,B,D

PHSA 

Public Health Service Act 

G,P,B,D

PI 

principal investigator 

package insert (approved product labeling)

P,B

PK 

pharmacokinetic 

P,B

PLA 

product license application 

D

PMA 

premarket approval 

G,P,B,D

PMS 

postmarket survelliance 

PO

per os (by mouth)

D

POS 

program operations staff 

PPA

Poison Prevention Act

G,P,B,D

PPC 

production and process controls 

PPI

patient package insert

PPO

policy and procedure order

G

PQ 

performance qualification

PR

pulse rate

PRIM & R

Public Responsibility in Medicine and Research

PRN

as needed

PTCC

Pharmacology/Toxicology Coordinating Committee (CDER)

P,B

PTEs 

patent term extensions 

G

PTO 

Patent and Trademark Office (Department of Commerce) 

PUD

peptic ulcer disease

Q

G,P,B,D

QA

quality assurance

G,P,B,D

QAU 

quality assurance unit 

GPBD

QC 

quality control 

QD

once daily

QID

four times a day

QL

quality of life

QNS

quantity not sufficient

QOD

every other day

G,P,B,D

QOL 

quality of life 

D

QSIT 

quality systems inspections technique 

D

QSR 

quality system regulation 

R

R & D

research and development

RAC

Reviewer Affairs Committee (CDER)

RADAR

risk assessment of drugs - analysis and response

D

RAE 

remedial action exemption 

RAPS

Regulatory Affairs Professionals Society

RCH

remove clinical hold

D

RCHSA 

Radiation Control for Health and Safety Act of 1968 

RCT

randomized clinical trial

RDE

remote data entry

RDT

rising-dose tolerance

G,P,B,D

ReGo 

reinventing government 

D

RFD 

request for designation 

RFDD

Regional Food and Drug Director

RL

regulatory letter

P,B

RLD 

reference listed drug 

G,P,B,D

RPM 

Regulatory Procedures Manual 

D

RTA 

refuse to accept 

RTF

refuse to file

P,B

 Rx

prescription

S

G,P,B,D

S&E 

safety and effectiveness 

G,P,B,D

SAE 

serious adverse event 

G,P,B,D

SAL 

sterility assurance level 

G,P,B,D

SBA or SBOA 

summary basis of approval 

G

SBREFA 

Small Business Regulatory Fairness and Enforcement Act 

SC

subcutaneous

study coordinator

D

SCGD 

special controls guidance documents 

SCSO

supervisory consumer safety officer

SD

standard deviation

D

SE 

substantially equivalent/substantial equivalence 

standard error

G

SEC 

Securities and Exchange Commission 

SEER

Surveillance, Epidemiology, and End Results (Registry of NCI)

SES

Senior Executive Service

SMART

submission management and review tracking

D

SMDA 

Safe Medical Devices Act of 1990 

SME

significant medical event

G,P,B,D

SMO 

site management organization 

P

sNDA 

supplemental new drug application 

 SNP

single nucleotide polymorphisms

G,P,B,D

SOPs 

standard operating procedures 

SQ

subcutaneous

D

SR 

significant risk 

SRS

spontaneous reporting system

D

SSE 

summary of safety and effectiveness 

D

SSED 

summary of safety and effectiveness data 

P

SUPAC 

scale-up and post-approval changes (FDA guidance) 

SX

symptoms

T

G,P,B,D

TESS 

treatment 

P

TFM 

tentative final monograph 

TID

three times a day

TK

toxicokinetics

TOP

topical

G,P,B,D

TRO 

temporary restraining order 

G

TSA 

Trade Secrets Acts 

U

UA

urinalysis

UKCCR

United Kingdom Coordinating Committee on Cancer Research

UNESCO

United Nations Educational Science and Cultural Organization

G

URAA 

Uruguay Round Agreements Act 

USAN

united states adopted name

G,P,B,D

USC 

United States Code

G

USDA

United States Department of Agriculture

G,P,B,D

USP 

United States Phamacopeia

USP-DI

United States Pharmacopeia-Drug Information

USP-NF

United States Pharmacopeia-National Formulary

USPC

U.S. Pharmacopeial Convention

USUHS

Uniformed Services University of the Health Sciences

V

D

V/V 

verification/validation 

D

VAI 

voluntary action indicated 

B

VAERS

vaccine adverse event reporting system

W

G

WEAC

Winchester Engineering and Analytical Center

WHO

World Health Organization

G,P,B,D

WL 

warning letter

WNL

within normal limits