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 Administration
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