120-day Safety Report

Amendment to a NDA due 120 days after the NDA is filed that contains a safety update.

30-day hold

Time period between filing a protocol under an IND and FDA OK to proceed with enrollment.

510(k)  

Premarket Notification Submission (United States)  

510(k)

A premarket notification submitted to FDA to demonstrate that the medical device to be marketed is as safe and effective or substantially equivalent to a legally marketed device. 510(k) refers to the section of the FD&C Act authorizing the submission of the premarket notification.

510K  

Premarket Notification Submission (United States)  

AAA  

Abdominal Aortic Aneurysm  

AAAS

American Association for the Advancement of Science

AABB

American Association of Blood Banks

AACC  

American Association for Clinical Chemistry (United States)  

AADA

Abbreviated Antibiotic Drug Application (primarily used for generics) 

AAHP  

American Association of Health Plans (United States)  

AAMI  

Association for the Advancement of Medical Instrumentation (United States)  

AAPS

American Association of Pharmaceutical Scientists

Abbreviated 510(k)

submission based on guidance document(s); special controls or standards.

ABHI  

Association of British Health Care Industries (United Kingdom) 

ABIMO  

Medical device trade association (Brazil)  

ABPI  

Association of the British Pharmaceutical Industry (United Kingdom)

ACC  

American College of Cardiology (United States)  

ACE

Adverse Clinical Event

ACGIH   

American Conference of Governmental Industrial Hygienists (United States)

ACII   

American Standard Code for Information Exchange (United States)

ACNP   

American College of Nuclear Physicians (United States)

ACR   

American College of Radiology (United States)  

ACRP   

American Clinical Research Professionals (United States)

ACS

American Chemical Society

Action Letter

Official communication of FDA informing NDA sponsor of an agency decision. Includes approvable, not approvable, clinical hold and warning letters.

Active Ingredient

Any drug component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.

ADA    

American Dental Association (United States)

ADA    

Americans with Disabilities Act (United States)

ADDM    

Association of Disposable Device Manufacturers

ADE

Adverse Drug Event, or Adverse Drug Experience

ADME    

Absorption, distribution, metabolism, and elimination (of a drug)

ADME

Absorption, Distribution, Metabolism, and Excretion

ADP

Automated Data Processing

ADR   

Adverse Drug Reaction

ADR

Adverse Drug Reaction

ADRAC    

(Australia)

Adulterated

Product is not made according to GMPs or is contaminated.

AE

Adverse Event

AER   

Adverse Event Report

AERS    

Adverse Events Reporting System

AERS

Adverse Event Reporting System

AESGP    

An OTC industry association in Europe

AETSA    

Agencia de Evaluación de Tecnologias Sanitarias de Andalucia (Spain)

AFDO

Association of Food and Drug Officials

AFSSAPS

Agence Française de Sécurité Sanitaire des Produits de Santé (France)

AGIM    

Belgian industry association (pharmaceuticals)

AGRD    

(Australia)

AGRF   

 Australian Genome Research Facility

AHCPR    

Agency for Health Care Policy and Research

AHCPR

Agency for Health Care Policy and Research (obsolete, use AHRQ)

AHRQ

Agency for Healthcare Research and Quality (pronounced “arc”)

AIC   

Adverse Incident Centre (United Kingdom - MDA)

AIDS   

Acquired Immune Deficiency Syndrome

AIMD   

Active Implantable Medical Device

AIMDD

Active Implantable Medical Device Directive

AIP

Application Integrity Policy: the policy contains the agency’s approach regarding the review of applications that may be affected by wrongful acts that raise significant questions regarding data reliability.

AIUM   

American Institute of Ultrasound in Medicine (United States)

AMA

American Medical Association

AMDM    

Association of Medical Device Manufacturers (Hungary)

AMDR    

Association of Medical Device Reprocessors

Amendment

Additions or changes to a NDA, PMA or PMA supplement still under review. Includes safety updates.

ANADA    

Abbreviated New Animal Drug Application (United States)

ANADA

Abbreviated New Animal Drug Application

ANAES   

Medical technology evaluation agency (France)

ANDA  

Abbreviated New Drug Application (United States- FDA)  

ANDA

Abbreviated New Drug Application (used for generic drugs)

ANIMAT    

Administración Nacional de Medicamentos, Alimentos y Tecnologia Médica (Argentina) http://www.anmat.gov.ar/principal.html

ANMV    

French national veterinary medicines agency

Annual report

An annual report to an active IND is required. Summaries of preclinical and clinical investigations, safety reports not previously filed and updates to CMC information are included. Report to be submitted by manufacturers of radiation emitting devices. Report to be submitted by sponsors of IDEs to IRBs and FDA (also called Progress Report).

ANOM    

Analysis of Means

ANOVA   

Analysis of Variance

ANPR   

Advance Notice of Proposed Rulemaking (United States)

ANSI    

American National Standards Institute (United States)

ANVS    

Agencia Nacional de Vigilancia Sanitaria (National Agency of Health Surveillance)
Brazilian healthcare monitoring agency

APA    

American Psychiatric Association (United States)

APA

American Pharmaceutical Association

APB    

Pharmacist's association (Belgium)

APhA

American Pharmaceutical Association

APHIS

Animal and Plant Health Inspection Service

API   

Application Program Interface

API    

Active Pharmaceutical Ingredient

API

Active Pharmaceutical Ingredient

APIFARMA   

Portugal

Approved

FDA designation given to drugs, biologics and medical devices that have approved marketing applications (NDA, BLA or PMA).

AQL

Acceptable Quality Level

ARC   

AIDS Related Complex  

ARC   

American Red Cross (United States)

ARTG   

Australian Register of Therapeutic Goods

ASA    

Acoustical Society of America (United States)

ASM

American Society for Microbiology

ASME    

American Society of mechanical Engineers (United States)

ASQ

American Society for Quality (formerly ASQC)

ASR    

Analyte Specific Reagent (United States - FDA)

ASTM   

American Society for Testing and Materials (United States)

ATCC    

American Type Culture Collection (United States)

ATF

Bureau of Alcohol, Tobacco and Firearms

AUA   

Authorised User Access (Australia)

AUC   

Area Under the Curve

AUST L   

Numbering scheme for Australian conformity mark

AUST R   

Numbering scheme for Australian conformity mark

AV   

Atrioventricular

B/F    

Bacteriostasis/Fungistasis (USP)

BACPAC    

Bulk Activities Post Approval Changes (United States - FDA)

BACPAC

Bulk Actives Post Approval Changes

BAH    

German medicines manufacturers association  

BAH   

OTC association (Germany)

Banned Device

A device that presents a substantial deception, unreasonable risk of injury or illness, or unreasonable direct and substantial danger to the public health.

BEI   

 Biological Exposure Indicies

BfArM

Federal Institute for Drugs and Medical Devices (Germany) http://www.bfarm.de/gb_ver/  

BHF   

Batch History File

BHR   

Batch History Record

BiMo   

Bioresearch Monitoring (United States - FDA)

BIO

Biotechnology Industry Organization

Biologic

Any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries in man.

BIRA    

British Institute of Regulatory Affairs

BL   

Biologics License (United States)

BLA   

Biologics License Application (United States - FDA)

BLA

Biologics License Application (replaces PLA/ELA)

Blinded Study

Clinical trial where the patient (single-blind) or patient and investigator (double-blind) are unaware of which treatment the patient receives. Involves use of multiple treatment groups such as other active, placebo or alternate dose groups. Sometimes termed “Masked.”

BMA    

British Medical Association (UK)

BMJ   

British Medical Journal (UK)

BPI    

German industry association of small- and medium-sized pharmaceutical companies in Germany

BSE  

Bovine Spongiform Encephalopathy  

BVmed   

German medical device industry association http://www.bvmed.de

CA    

Certification Authority

CA    

Competent Authority

CA

Competent Authority Governmental agency in each EC member state responsible for monitoring and enforcing the MDD.

CAB   

Conformity Assessment Body

CAB   

Conformity Assessment Body (EU)

CABG    

Coronary Artery Bypass Graft

CAD    

Computer Aided Design

CADREAC    

Collaboration Agreement of Drug Regulatory Authorities of EU-associated Countries

CAE   

CAM   

CANDA

Computer Assisted New Drug Application (obsolete)

CANDA    

Computer Aided New Drug Application (United States)

CAP    

College of American Pathologists (United States)

CAPA

Corrective and Preventive Actions

CAPLA

Computer Assisted Product License Application (obsolete)

CAPLA   

Computer Aided Product License Application (United States)