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)

CAPRA

Canadian Association of Professional Regulatory Affairs

CAS   

CBE-30

Changes Being Effected within 30 days (applies to manufacturing changes)

CBER

Center for Biologics Evaluation and Research

CBER   

Center for Biological Evaluation and Research (United States - FDA)

CCITT   

Committe Consultatif International Telegraphique et Telephonique

CCMA

Certified Color Manufacturer’s Association

CDC

Centers for Disease Control and Prevention

CDC    

Centers for Disease Control and Prevention (United States)

CDER

Center for Drug Evaluation and Research

CDER   

Center for Drugs Evaluation and Research (United States - FDA)

CDRH

Center for Devices and Radiological Health

CDRH   

Center for Devices and Radiological Health (United States - FDA)

CE   

Cost Effectiveness

CE   

Conformity mark (EU)

CE Mark

Mark signifying compliance with applicable European Community directive (e.g., MDD, IVDD, or AIMDD).

CEEC   

Central and Eastern European Countries (Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, and Slovenia)

CEN    

Comite Europeen de Normalisation (European Committee of Standardization) - European Committee for Satndardization (EU)

CENELC   

CENELEC   

CEO    

Chief Executive Officer

CF

Consent Form (document used to inform a potential subject of the risks and benefits of a clinical trial)

CFG

Certificate to Foreign Government (Required by certain countries to prove that exported product is being manufactured to the requirements of GMPs; provided by FDA for export of legally marketed devices.)

CFI   

Court of First Instance (EU)

CFO   

Chief Financial Officer

CFR

Code of Federal Regulations

CFR   

Code of Federal Regulations (United States)

CFSAN

Center of Food Safety and Applied Nutrition

CFSAN    

Center for Food Safety and Nutrition (United States - FDA)

CFU    

Colony Forming Unit

CGMP

Current Good Manufacturing Practice

CGMP    

Current Good Manufacturing Practices (United States - FDA)

CGMP    

Current Good Manufacturing Practice

CGSB   

Canadian General Standards Board (Canada)

CH

Clinical Hold

CHPA

Consumer Health Products Association

CIAA   

Confederation of the EU Food and Drink Industry

CIE    

International Commission on Illumination

CIO    

Chief information Officer

CIOMS

Council for International Organizations of Medical Sciences (The CIOMS form may be used for post-approval international AE reporting.)

CIOMS    

(Australia)

CISPR   

Class I Device

Low risk device requiring general controls to assure safety and effectiveness.

Class II Device

Requires general and special controls to ensure S&E. Special controls may include mandatory performance standards, patient registries for implantable devices, and postmarket surveillance. Requires 510(k) unless exempted. May require clinical trials.

Class III Device

Requires general controls, special controls, and PMA; includes devices that are life sustaining, life supporting or pose potential risk to patient. PMA may require clinical trials.

Clearance

Devices that receive permission to market, not approval. Designation based on demonstrating substantial equivalence to a preamendment device or another device reviewed under section 510(k) of the FD&C Act.

CLIA    

CLIAC   

Clinical Hold

FDA order to delay proposed clinical investigation or to suspend an ongoing investigation.

CMA    

Central Medicines Authority

Cmax   

Concentration at maximum

CMC

Chemistry, Manufacturing and Controls

CMC   

Chemistry, Manufacturing and Controls (US FDA/CDER and CBER)

CMCCC   

Chemistry Manufacturing Controls Coordinating Committee (United States - FDA - CDER)

CME

Continuing Medical Education

CMS

Centers for Medicare and Medicaid Services

CMS   

CNAM   

Caisse natiuonale de l'assurance maladie (French public health insurance agency)

COCIR    

Radiological and electromedical industry association

COE

Certificate of Exportability (Is required by certain countries for the export of unapproved devices not sold or offered for sale in the United States; issued by FDA to the exporter.)

CofA    

Certificate of Analysis

Commercial Distribution

Any distribution of a device intended for human use, which is offered for sale but does not include: internal or interplant transfer within the same parent, subsidiary or affiliate company; or any device with an approved exemption for investigational use.

Compassionate Use IND

(obsolete) see Treatment IND

Complaint

Any written, electronic or oral communication alleging deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a product after release for distribution.

Component

Any ingredient/part intended for use in the manufacture of a drug, device, cosmetic, biologic or IVD product, including those that may not appear in the finished product.

COO    

Chief Operating Officer

COSHH   

Control of Substances Hazardous to Health (UK)

Cosmetic

Articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractive- ness or altering appearance; and Articles intended for use as a component of any such article; except that such term shall not include soap.

COSTART

Coding Symbols for a Thesaurus of Adverse Reaction Terms (Used to code AE’s to standard preferred terms and body systems-will be replaced by MedDRA.)

CPAC    

Central Pharmaceutical Affairs Council  (Japan - NIHS)

CPAP    

Continuous Positive Airway Pressure

CPG    

Compliance Policy Guide (US FDA)

CPMP

Committee for Proprietary Medicinal Products (Europe)

CPMP    

Committee for Proprietary Medicinal Products (EU)

CPS   

Crown Prosecution Service (UK)

CPSC

Consumer Product Safety Commission

CPSC    

Consumer Product Safety Commission (US)

CRA

Clinical Research Associate

CRADA

Cooperative Research and Development Agreement (with NIH)

CRADA    

CRC

Clinical Research Coordinator

CRF

Case Report Form (Used to record data collected in a clinical trial.)

CRO

Contract Research Organization

CRT    

Cathode Ray Tube

CSA    

Canadian Standards Association

CSF    

Cerebral Spinal Fluid

CSM   

Committee on Safety Of Medicines (United Kingdom) http://www.open.gov.uk/mca/csmhome.htm

CSO

Consumer Safety Officer (Usually the contact person for Sponsors at FDA. Also known as the project manager.)

CT    

Controlled Trials (Australia)

CTD

Common Technical Document

CTD    

Common Technical Document

CTE   

Clinical Trial Exemption (Australia)

CTFA

Cosmetic, Toiletry & Fragrance Association

CTN   

Clinical Trial Notification (Australia)

CTX

Clinical Trial Exemption (Europe). (Permission to ship drug for investigational purposes; equivalent to IND.)

CUF   

Italian drug committee

Custom Device

is not generally available in finished form for purchase or dispensing by prescription; is not offered for commercial distribution through labeling or advertising; is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient; is intended to meet the special needs of the physician or or dentist.

CV   

Coefficient of Variation

CVM

Center for Veterinary Medicine

CVM    

Center for Veterinary Medicine (United States - FDA)

CVMP   

Committee for Veterinary Medicinal Products (EU)

CZE   

Capillary Zone Electrophoresis

D&D

Design and Development Plan

DA    

Designated Authority

DAMOS   

DB    

Device Bulletin (UK - MDA)

DCGI   

Drug Controller General of India

DCLD    

Division of Clinical Laboratory Devices (US - FDA - CDRH - ODE)

DDE    

Department of Drug Evaluation (Korea)

DDMAC

Division of Drug Marketing, Advertising, and Communications

DDR    

Department of Medicinals Devices & Radiation Health (Korea)

DEA

Drug Enforcement Administration

Debarment

An action against an individual restricting him/her from directly or indirectly providing services in any capacity to a firm with an approved or pending drug/device product application. A debarred corporation is prohibited from submitting or assisting in the submission of any NDA or ANDA (disqualification for devices PMA submission).

Declaration of Helsinki

Ethical principles for medical research involving human subjects. Trials conducted under GCP generally follow the Declaration of Helsinki.

DEP   

Device Evaluation and Publications (UK - MDA)

DES   

Data Encryption Standard

DESI

Drug Efficacy Study Implementation

DFA    

Department of Food Additives Evaluation (Korea)

DFE    

Department of Food Evaluation (Korea)

DG III    

EC Commission's Directorate General for Industry

DG III-E-3   

Pharmaceuticals and Cosmetics Unit of DG III

DG IV   

Agriculture

DG V   

DG XXIV   

Consumer

DHF

Design History File (Describes the design of a finished device.)

DHF   

Design History File

DHHS

Department of Health and Human Services

DHHS    

Department of Health and Human Services (United States)

DHR

Device History Record. (Contains the production history of a device.)

DI   

Distilled

DIA

Drug Information Association

DIA   

Drug Information Association (United States)

DIMDI    

German Institute for Medical Documentation and Information (for EU devices database)

DIN   

Deutsches Institute fur Normung (Germany)

DMDA    

Danish industry association for medical devices

DMEPOS    

Durable Medical Equipment, Prosthetics and Orthotics

DMF

Drug Master File (A Drug Master File is a submission to FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging and storing of one or more human drugs.)

DMF   

Drug Master File (United States) FDA)

DMR

Device Master Record (A compilation of records containing the procedures and specifications for a finished device.)

DNA   

DNB    

Department of Natural Medicinals & Biologics Evaluation (Korea) 

DNM    

Department of National Medicinals (Korea)

DOE    

Department of Energy (United States)

DOE   

Design of Experiments

DOH   

Department of Health (United Kingdom)

DOPA    

Department of Pathology (Korea - NITR)

DOPH    

Department of Pharmacology (Korea - NITR)

DOT    

Department of Toxicology (Korea - NITR)

DOT   

Department of Transportation (United States)

DP   

Department Procedure

DPI   

Dry Powder Inhaler

DRA   

Drug Regulatory Affairs

DRA   

Drug Regulatory Authority (EMEA)

DRG   

Diagnosis related group

DRGs    

Diagnosis related groups

Drug

Any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man.

Drug Product

A finished dosage form (e.g., tablet, capsule, solution, etc.) that contains an active drug ingredient generally, but not necessarily, associated with inactive ingredients. This also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.

DSEB    

Drug Safety Evaluation Branch (Australia)

DSMA   

Division of Small Manufacturers Assistance (US - FDA)

DSMB

Data and Safety Monitoring Board

DSMB    

Data Safety Monitoring Board (US)

DSS   

Digital Signature System

DTC

Direct-to-Consumer (drug advertising)

DTC    

Direct-to-consumer (UK)

DTD    

Document Type Definition

DTI    

Department of Trade and Industry (UK)

DTS1    

Device Technology & Safety Section 1 - Sterile, Surgical and In vitro Diagnostic Devices (UK - MDA)

DTS2   

Device Technology & Safety Section 2 - Rehabilitation and Transfer Equipment (UK - MDA)

DTS3   

Device Technology & Safety Section 3 - Wheelchairs and associated Seating/Supports (UK - MDA)

DTS4   

Device Technology & Safety Section 4 - Diagnostic Imaging, Surgery & Therapy, Physiological Measurement, Audiology and Disability Equipment (UK - MDA)

DTS5   

Device Technology & Safety Section 5 - Critical Care Devices (UK - MDA)

DTS6   

Device Technology & Safety Section 6 - Implants and Materials (UK - MDA)

EA

Environmental Assessment

EBAF   

Endometrial Bleeding Associated Factor

EBM    

German doctors' fee schedule

EBXL    

Electron Beam Cross Linking

EC

European Commission, European Community or Ethics Committee

EC    

European Community

ECG   

Electrocardiogram

ECHR    

European Convention on Human Rights

ECHTA    

European Co-ordination for Health Technology Assessment

ECJ   

European Court of Justice (EU)

ECO

Emergency Change Order

ECOFIN    

ECOSOC   

EC Economic and Social Committee (EU)

ECPHIN   

European Community Pharmaceutical Information Network (ETOMEP) http://www.jrc.org/isis/etomep/activities/ecphin.asp

ECRI   

ED    

Erectile Dysfunction

EDI   

Electronic Data Interchange

EDIFACT    

Electronic Data Interchange for Administration, Commerce and Transport (United Nations)

EDMA    

European Diagnostics Manufacturers Association

EEA    

European Economic Area

EEC   

EEG   

Electroencephalograph

EFOIA    

Electronic Freedom of Information Act (United States)

EFPIA   

European Federation of Pharmaceutical Industry Associations

EFTA

European Free Trade Association

EFTA   

European Free Trade Area

EG   

Expert Group

EGA    

European Generics medicines Association

EIR

Establishment Inspection Report

EL    

Establishment License (United States)

ELA

Establishment License Application (obsolete, use BLA)

ELA   

Establishment License Application (United States)

EMBS   

Engineering in Medicine and Biology Society (United States)

EMC    

Electromagnetic Compatibility

EMEA

The European Agency for the Evaluation of Medicinal Products

EMEA    

European Medicines Evaluation Agency (EU) http://www.eudra.org/emea/emea.html

Emergency Use IND

FDA authorization of shipment of drug for a specific emergency use for life-threatening or serious disease with no alternative treatment.

EMI   

Electromagnetic Interference

EN    

EO    

Ethylene Oxide

EP    

European Parliment

EPA

Environmental Protection Agency

EPA   

Environmental Protection Agency (US)

EPAR   

European Pharmaceutical Assessment Report

EPO   

European Patent Office (EU)

ERA   

European and Regulatory Affairs (UK - MDA)

ERA   

European Regulatory Affairs (journal)

ESD   

Electrostatic Discharge Association (US)

ESD    

Electrostatic Discharge

ESRA    

ESTRI   

Electronic Standards for Transmission of Regulatory Information

EtO    

Ethylene Oxide

ETO    

Ethylene Oxide

ETOMEP   

European Technical Office for Medicinal Products http://www.jrc.org/isis/etomep/index.asp#top

EU

European Union (15 Member States: Belgium, Germany, France, Italy, Luxembourg, the Netherlands, Denmark, Ireland, the United Kingdom; Greece; Spain, Portugal; Austria, Finland and Sweden)

EU   

European Union

EUCOMED   

European medical device trade association

EUDAMED   

EC Medical Device Database

EUDRA   

EVG   

Endovascular Graft (ISCVS)

Expected Life

Time a device is expected to remain functional after placement into service.

Expiration Date

Date printed on label of product indicating the end of the useful life. Length of expiration period determined by stability studies and negotiated with FDA for drugs and IVDs.

FAR

Field Alert Report

Farmindustria    

Italian industry association

Fast Track

Accelerated NDA and review. Allows surrogate endpoint.

FCC

Federal Communications Commission

FCC   

Federal Communications Commission (United States)

FD&C Act (FDCA)

Federal Food, Drug and Cosmetic Act (also abbreviated as FFDCA)

FDA

Food and Drug Administration

FDA    

Food and Drug Administration (United States)

FDAMA

FDA Modernization Act of 1997

FDAMA   

FDA Modernization Act of 1997 (United States)

FDC   

Food Drug and Cosmetic (United States)

FDERA

FDA Expert Reform and Enhancement Act of 1996

FDLI

Food and Drug Law Institute

FDP   

Fibrin/Fibrinogen Degradation Products

FEFANA   

A European feed additive industry association

FFDCA

Federal Food, Drug, and Cosmetic Act

FIFRA   

Federal Insecticide, Fungicide and Rodenticide Act (United States)

FMEA    

Failure Modes and Effects Analysis

FMECA

Failure Mode, Effects and Critical Analysis

FOI   

Freedom of Information

FOIA

Freedom of Information Act

FOIA    

Freedom of Information Act (United States)

FPLA

Fair Packaging and Labeling Act

FQPA    

Food Quality Protection Act of 1996 (US)

FR

Federal Register

FR   

Federal Register (United States)

FSPF    

French pharmacists association

FTA    

Fault Tree Analysis

FTC

Federal Trade Commission

FTP   

File Transfer Protocol

FY   

Fiscal Year (United States)

GAO

General Accounting Office

GAO    

Government Accounting Office (United States)

GATT

General Agreement on Tariffs and Trade

GB   

Gigabyte

GC

General Counsel (FDA)

GC    

Gas Chromatography

GC/MS   

Gas Chromatography/Mass Spectrometry

GCP

Good Clinical Practice (Refers to the regulations and requirements that must be complied with while conducting a clinical study. These regulations apply to the manufacturers, sponsors, clinical investigators, institutional review boards and the medical device.)

GCP   

Good Clinical Practice

GCPs   

Good Clinical Practices

Generic Drug

Drugs manufactured and approved after the original brand name drug has lost patent protection. Marketing approval filed with ANDA.

GGP    

Good Guidance Practice (United States)

GHTF   

Global Harmonization Task Force http://www.ghtf.org

GI   

Gastrointesinal

GINC    

Global Information Network on Chemicals

GLP

Good Laboratory Practice (Refers to nonclinical laboratory studies that support or are intended to support applications for research or marketing permits.)

GLP    

Food Laboratory Practice (Australia)

GLP   

Good Laboratory Practices (United States)

GMC    

Genetically Modified Crop

GMDN   

Global Medical Device Nomenclature

GMO   

Genetically Modified Organism

GMP

Good Manufacturing Practice (for devices, see Quality System Regulation 1997)

GMP   

Good Manufacturing Practice

GMPs   

Good Manufacturing Practices

GPO   

Group Purchasing Organization (United States)

Grandfathered

Drugs on the market before 1938. Devices on the market before 1976.

GRAS(E)

Generally Recognized as Safe (and Effective)

GRP

Good Review Practice

GRP    

Good Regulatory Practices

Guidance

Documents published by FDA to provide interpretation of regulations.

Guidance

Documents published by FDA to provide interpretation of regulations.

HA    

Hyaluronic Acid

HACCP

Hazard Analysis and Critical Control Point (inspection technique)

HACCP   

Hazard Analysis Critical Control Points (United States - FDA)

HCFA

Health Care Financing Administration (determines Medicare payment system) (obsolete, use CMS)

HCFA   

Health Care Financing Administration (United States)

HCT    

Hematocrit

HDC   

High Density Collagen

HDE

Humanitarian Device Exemption

HDE   

Humanitarian Device Exemption (United States - FDA)

HDPE   

High density polyethylene

HEPA   

HHS

Health and Human Services (Department of)

HHS   

Health and Human Services (United States)

HIMA   

Health Industry Manufacturers Association (United States) now called "AdvaMed"

HIV    

Human Immunodeficiency Virus

HL7   

Health Level 7 (an ANSI standard used to facilitate the electronic interchange of data in a healthcare environment)

HLC    

Healthcare Leadership Council (United States)

HMD    

Head Mounted Display

HMO

Health Maintenance Organization

HMO   

Health Maintenance Organization (US)

HN    

Hazard Notice (UK - MDA)

HPB

Health Protection Branch (Canada’s equivalent of FDA)

HPB    

Health Protection Branch (Canada)

HSE   

Health and Safety Executive (UK)

HTLV   

Human T-Cell Lymphotropic Virus

HTML   

Hypertext Markup Language

HTTP   

Hypertext Transfer Protocol

HUD

Humanitarian Use Device

I/O   

Input/Output

IB

Investigator’s Brochure

IC

Informed Consent

IC    

Informed Consent (United States)

ICH

International Conference on Harmonization (participants include Europe, Japan and US)

ICH   

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

ICSR   

Individual Case Safety Report

IDE

Investigational Device Exemption

IDE    

Investigational Device Exemption or Investigational Device Exemption Application  (United States - FDA)

IDMC

Independent Data Monitoring Committee

IDN    

Integrated Delivery Network

IDSMB

Independent Data Safety Monitoring Board

IEC    

International Electrotechnical Commission

IEEE    

Institute of Electrical and Electronic Engineers

IES    

Illuminating Engineering Society (US)

IESNA    

IEST    

Institute of Environmental Sciences and Technology

IFPMA    

International Federation of Pharmaceutical Manufacturers Associations

IG   

Inspector General (US)

IHC    

Immunohistochemistry reagents (US - FDA)

IKS   

Interkantonale Kontrollstelle für Heilmittel - Intercantonal regulatory body (Switzerland)

IMB    

Irish Medicines Board (Ireland)

IMDA   

Independent Medical Distributors Association (US)

IMDRM    

International Medical Device Regulatory Monitor (journal)

IMRT   

Intensity Modulated Radiation Therapy

Inactive Ingredient

Any component of a drug product other than an active ingredient such as excipients, vehicle and binders.

INAD

Investigational New Animal Drug

INAMI    

Belgian health insurance body

IND

Investigational New Drug (application)

IND    

Investigational New Drug or Investigational New Drug Application (United States - FDA)

INDOMED    

Indian Device Industry Group

INFARMED    

Instituto Nacional da Farmácia e do Medicamento (Portugal) http://www.infarmed.pt/home.html (in Portuguese)

Information Amendment

Includes most submissions under an active IND, such as new protocols, final study reports, safety reports, CMC information, etc. The initial IND is number 000 and each subsequent serial amendment receives the next consecutive number.

INMM   

Institute of Nuclear Materials Management (United States)

INN

International Non-proprietary Names

Intended Use

Objective intent of persons legally responsible for labeling a device.

Investigator IND

An individual investigator submits a protocol and IND rather than the manufacturer. A letter of authorization allows FDA to review the sponsor’s DMF. The investigator, not the manufacturer, is responsible for maintaining the IND.

INVIMA    

Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Columbia) http://www.sinpro.gov.co/invima/indice.htm (in Spanish)

IOL   

Intraocular lens

IPRM    

International Pharmaceutical Regulatory Monitor (journal)

IQ   

Installation Qualification

IRB

Institutional Review Board or Independent Review Board

IRB   

Institutional Review Board (United States)

IRC   

Institutional Review Committee (United States)

IRF    

International Review Forum (United States) http://www.irf.to

ISAC    

International Society for Analytical Cytology

ISBT    

International Society of Blood Transfusion

ISCVS    

International Society for Cadiovascular Surgery

ISDB    

International Society of Drug Bulletins

ISDN   

Integrated Services Digital Network

ISO

International Organization for Standardization (not an acronym)

ISO    

International Organization for Standardization

ISPE

International Society for Pharmaceutical Engineering; International Society for Pharmacoepidemiology

IUO

Investigational Use Only

IUO    

Investigational Use Only (United States - FDA)

IUPAC   

International Union of Pure and Applied Chemistry

IV    

Intravenous

IVD

In Vitro Diagnostics

IVD    

In Vitro Diagnostic

IVDAC    

In Vitro Diagnostic Advisory Committee (UK - MDA)

IVDD

In-Vitro Diagnostic Device Directive (European)

IVDD   

In Vitro Diagnostic Device

IVDP   

In Vitro Diagnostic Product

IVF   

In Vitro Fertilization

IVMP   

JIT   

Just In Time

JMHW

Japanese Ministry of Health and Welfare

JPMA    

Japan Pharmaceutical Manufacturers Association (Japan)

JWG   

Joint Working Group (ISO/IEC)

KB    

Kilobyte

KFDA    

Korea Food and Drug Administration (Korea)

Label

Any display of written, printed or graphic matter on the immediate container or package of, or affixed to, any article.

Labeling

All written, printed or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment in interstate commerce. Includes user manuals, brochures, advertising, etc.

LAL    

Limulus Amebocyte Lysate

LAN    

Local Area Network

LAR   

Laboratory Animal Resources (Korea - NITR)

LBS    

Literature Based Submission (Australia)

LCD   

Liquid Crystal Display

LDPE    

Low density polyethylene

LHF    

Lot History File

LHR   

Lot History Record

LIA   

Laser Institute of America (United States)

LOA

Letter of Authorization (A letter from the holder of a Drug Master File to FDA, authorizing a company to reference the DMF.) also Letter of Agreement

LOA   

Letter of Authorization (United States - FDA)

LVP    

Large Volume Parenteral (United States)

M2    

Multidisciplinary Group 2 (ESTRI) of ICH

MA

Marketing Authorization

MA    

Marketing Authorization

MAC   

Microbiology Advisory Committee (UK - MDA)

MACEAC

Maximum Allowable Cost-Estimated Acquisition Cost

MAH   

Marketing Authorization Holder

MANSEV    

Market Authorisation by Network Submission and Evaluation (ETOMEP) http://www.jrc.org/isis/etomep/activities/mansev.asp

MAPI   

Mail Application Programming Interface

MAPP

Manual of Policy and Procedures

Market Withdrawal

Firm-initiated removal or correction of a device, drug or biologic involving a minor violation of the FD&C Act not subject to legal action by FDA.

MB    

Megabyte

MBM    

Meat and Bone meal (EU)

MCA  

Medicines Control Agency (United Kingdom) http://www.open.gov.uk/mca/homemain.htm  

MCA   

Medicines Control Agency (UK)

MCA    

Medicines Control Agency (UK) http://www.open.gov.uk/mca/mcahome.htm

MCH    

Mean Corpuscular Hemoglobin

MCHC   

Mean Corpuscular Hemoglobin Concentration

MCV   

Mean Corpuscular Volume

MDA   

Medical Devices Agency (United Kingdom)

MDA   

Medical Device Amendments (United States)  

MDA    

Medical Devices Agency (UK) http://sss.medical-devices.gov.uk/

MDD

Medical Device Directive (European)

MDD   

Medical Devices Directive (EU)

MDI   

Metered Dose Inhaler

MDMA   

Medical Device manufacturers Association (United States)

MDR

Medical Device Reports

MDR    

Medical Device Report (United States - FDA)

MDR   

Medical Device Reporting (United States - FDA)

MEB   

Medicines Evaluation Board http://www.cbg-med.nl/index.htm (Netherlands)

MedDRA

Medical Dictionary for Regulatory Activities (Standard medical terminology coding dictionary (International), which will replace both COSTART and WHOART.)

MedDRA    

Medical Dictionary for Regulatory Activities

MEDEC    

Canadian medical device industry association (Canada) http://www.medec.org/

Medical Device

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory that is: Recognized in the official National Formulary or US, or any supplement;

Intended to affect the structure or any function of the body of man or other animals; and that does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for achievement of any of its primary intended purposes. (Section 201(h) of FD&C Act)

MEDSAFE    

New Zealand Medicines and Medical Devices Safety Authority http://www.medsafe.govt.nz/indexother.htm

 MedWatch

FDA program for voluntary and mandatory reporting of AEs and product problems. Use FDA Form 3500 or 3500A.

MEDWATCH   

(United States)

Member State

Member of EU

MERCOSUR   

Argentina, Bolivia, Brazil, Chile, Paraguay, and Uruguay group for harmonization in GMPs and registration requirements

MERGE    

Method for Evaluating Research and Guidance Evidence (Australia)

MF   

Master File

MFG   

Manufacturing

MHLW    

Ministry of Health, Labor and Welfare (Japan)

MHW

Ministry of Health and Welfare (Japan’s equivalent of FDA)

MHW   

Ministry of Health and Welfare (Japan)  http://www.mhw.go.jp/english/index.html  

MICS    

Minimally Invasive Cardiac Surgery

MIL-STD   

Military Standard (United States)

MIME    

Multi-purpose Internet Mail Extensions

MINE    

Pharmaceutical information network (UK)

Misbranded

Designation given to a product that is incorrectly labeled (i.e., false or misleading or fails to include information required by law).

MKT   

Marketing

MOH

Ministry of Health (various non-US nations; similar function to FDA)

MOH   

Ministry of Health (UK) http://www.open.gov.uk/doh/dhhome.htm

MOU

Memoranda of Understanding (Agreement between FDA and regulatory authority in another country that allows mutual recognition of inspections.)

MOU    

Memorandum of Understanding

MPA   

Medical Products Agency (Sweden) http://www.mpa.se/sve/nyindex.htm (in Swedish) http://www.mpa.se/eng/index.htm (in English)

MPCC

Medical Policy Coordinating Committee (US)  

MR 

Mutual Recognition  

MRA

Mutual Recognition Agreement  

MRFG   

Mutual Recognition Facilitation Group (EMEA) http://heads.medagencies.org/

MRL   

Maximum Residue Limit

MRP   

Mutual Recognition Procedure

MS   

Mass Spectrometry  

MSDS

Material Safety Data Sheet

MSQA   

Mammography Quality Standards Act of 1992 (United States)

MSSO   

Maintenance and Support Services Organization

MTBF   

Mean Time Between Failure

NADA

New Animal Drug Application

NADA   

New Animal Drug Application (United States)

NAF

Notice of Adverse Findings

NAFTA

North American Free Trade Agreement

NAFTA   

NAI

No Action Indicated (indicated on FDA Form 483 following an inspection)

NAPM    

National Association of Photographic Manufacturers, Inc. (United States)

NAT    

Nucleic Acid Testing

NB

Notified Body (European)

NB    

Notified Body

NCCLS

National Committee for Clinical Laboratory Standards

NCCLS   

National Committee for Clinical Laboratory Standards (United States)

NCE

New Chemical Entity

NCE   

New Chemical Entity (Australia)

NCFA   

Health Care Financing Administration (United States)

NCL  

National Chemistry Laboratory  (Korea)  

NCR

No Carbon Required (Paper used for CRFs or other documents where multiple copies are needed.)

NCRPM    

National Council on Radiation Protection & Measurements (United States)

NCTR

National Center for Toxicological Research

NDA

New Drug Application

NDA    

New Drug Application (United States - FDA)

NDA-Field Alert

Report to FDA within three working days information on any distributed drug product that has contamination, significant chemical or physical change, deterioration, batch failure or labeling causing mistaken identity.

NDC

National Drug Code (1st five digits identify establishment, last five digits identify drug name, package size and drug type.)

NDF

New Dosage Form

NDI    

National Drug Institute (Belgium)

NDI    

National Drug Institute (Bulgaria)

Nefarma   

Dutch pharmaceutical organization

NEMA   

National Electrical Manufacturers Association (United States)

NERA    

National Economic Research Associates (UK) http://wwwnera.com

NESMP    

National Experimental Station for Medicinal Plants (Korea)

NF

National Formulary (incorporated into the USP-NF)

NF    

National Formulary (United States)

NFPA    

National Fire Protection Association (United States)

NGAP    

Nomenclature génerale des actes professionnels (France)

NHMRC    

National Health and Medicines Research Council (Australia)

NHS    

National Health Service (United Kingdom)

NIA

National Institute on Aging

NICE    

National Institute for Clinical Excellence (United Kingdom)

NIH

National Institutes of Health

NIH    

National Institutes of Health (United States)

NIHCC   

NIHS    

National Institute of Health Sciences  (Japan)

NIPID    

National Institute for the Prevention of Infectious Disease (Korea)

NISR    

National Institute of Safety Research (Korea)

NITR    

National Institute of Toxicological Research (Korea)

NLM

National Library of Medicine

NME

New Molecular Entity

NME    

New Molecular Entity

NOON   

Notice of Opportunity for Hearing (United States)

NORD

National Organization of Rare Disorders

NPR    

Notice of Proposes Rulemaking (United States)

NRC

National Research Council or Nuclear Regulatory Commission

NRTL   

NSE

Not Substantially Equivalent (Designation for device that does not qualify for 510(k) clearance. May require a PMA.)

NSE    

Not Substantially Equivalent (United States)

NSF

National Science Foundation

NSR

Nonsignificant Risk

NTAG   

Nuclear Technical Advisory Group (United States)

OAI

Official Action Indicated (indicated on FDA Form 483 following inspection)

OC

Office of the Commissioner

OC    

Office of Compliance (United States - FDA)

OCI

Office of Criminal Investigation

ODE

Office of Device Evaluation

ODE    

Office of Device Evaluation (United States - FDA- CDRH)

OECD   

OEM    

Original Equipment Manufacturer

OEP    

Hungarian national healthcare insurance body  

OHIP   

(United States- FDA - CDRH)

OIE    

Office of Epizootics (EU)

OIG   

Office of the Inspector General (United States)

OLA   

Optical Laboratories Association (United States)

OMB    

Office of Management and Budget (United States)

OPA

Office of Public Affairs

OPCAB    

Off-Pump Coronary Artery Bypass

Open Label Study

A clinical trial where subjects and investigators are aware of the treatment received.

OQ   

Operational Qualification

ORA

Office of Regulatory Affairs (FDA)

ORA   

Office of Regulatory Affairs (United States - FDA)

Orange Book

FDA published listing of Approved Drug Products with Therapeutic Equivalence Evaluations (has an orange cover).

Orphan Drug

Drugs for a disease or condition that affects less than 200,000 persons in the US or occurs in more than 200,000 and for which there is no reasonable expectation that costs of developing and making available a drug for such a disease or condition will be recovered from sales in the US.

OSHA

Occupational Safety Health Administration

OSHA    

OTC

Over-the-Counter (Nonprescription drugs receive this designation.)

OTC    

Over the Counter

PACSAS   

Post Approval Changes - Sterile Aqueous Solutions (United States - FDA)

PACT    

Prevention, Assessment, Corrective Action and Training

PAGB    

Proprietary Association of Great Britain

PAI

Pre-approval Inspection

PAP    

Prostatic Acid Phosphatase

PART    

Personal Analyzer for Rapid Test

Patient

A person under a doctor’s care for a particular disease or condition.

PC    

Personal Computer

PCB    

Printed Circuit Board

PD

Pharmacodynamics (Study of the reactions between drugs and living structures.)

PDA

Parenteral Drug Association

PDF    

Portable Document Format (Adobe)

PDMA

Prescription Drug Marketing Act

PDP

Product Development Protocol (for medical devices)

PDP   

Product Development Protocol (United States - FDA)

PDR

Physician’s Desk Reference

PDUFA

Prescription Drug User Fee Act of 1992

PDUFA    

Prescription Drug User Fee Act (United States)

PDX   

Portable Document Index

PECA    

Protocol for European Conformity Assessment (European Union and Hungary, Poland, Czech Republic))

PEG    

Polyethylene Glycol

PEI    

Paul Ehrlich Institute (German Federal Institute for Sera and Vaccines)

PEM   

  Privacy Enhanced Mail

PET    

PGEU    

Pharmaceutical Group of the European Union

Pharmacovigilance

Adverse event monitoring and reporting.

Phase I

Initial safety studies in humans. May be as few as 10 subjects, often in healthy volunteers, includes PK, ADME and dose escalation studies. Usually open label.

Phase II

Clinical trials of approximately 100-300 subjects with the condition of interest. Includes PK, dose ranging, safety and efficacy. Well-controlled.

Phase III

Larger well-controlled clinical trials of 100’s to 1000’s of subjects. Includes both safety and efficacy data. Generally need two well-controlled studies to establish efficacy.

Phase IV

Clinical trials performed post market approval to support labeling and advertising or to fulfill safety requirements required by FDA at the time of NDA approval.

PHF    

Parathyroid Hypertensive Factor

PhRMA

Pharmaceutical Research and Manufacturers of America

PhRMA    

Pharmaceutical Research and Manufacturers of America (US)

PHS

Public Health Service

PHS    

Public Health Service (US)

PHS Act   

Public Health Service Act

PI

Package Insert (approved product labeling) or Principal Investigator

PI   

Parallel Import (EU)

PI    

Product Information (Australia)

PICT   

Macintosh Vector File

PIL    

Patient Information Leaflet (UK)

PIL   

Patient Information Leaflet (EMEA)

PK

Pharmacokinetics (Study of the processes of ADME of chemicals and medicines.)

PK   

Pharmacokinetic

PL   

Product License (United States)

PLA

Product License Application (obsolete, use BLA)

PLA   

Product License Application (United States)

Placebo

A drug product fashioned to look like an active drug but containing no active ingredient. Used in clinical trials to blind or mask the patient or investigator as to the treatment received.

PLLA   

Poly-L-Lactic Acid

PLT    

Platelet

PMA

Premarket Approval. (Marketing application required for Class III devices.)

PMA   

Premarket Approval or Premarket Approval Application (US)

PMAA   

Premarket Approval Application (US)

PMAs   

Premarket Approval Applications (US FDA)

PMN

Premarket Notification (510(k) for Class I and II devices)

PMR    

Percutaneous tramsmyocardial revasularization

PMS

Postmarketing Surveillance (Ongoing monitoring of the safety of approved drugs. May include Phase IV studies and AE reporting.)

PPA

Poison Prevention Act

PPI

Patient Package Insert

PPRS    

Prescription Pricing Regulation Scheme (UK)

PQ   

Performance Qualification

PRA   

Paperwork Reduction Act (United States)

Preclinical Studies

Animal studies of PK and toxicity generally performed prior to clinical studies. Must comply with GLP.

Priority Review (P)

FDA review category for drugs that appear to represent an advance over available therapy. NDA or BLA receives a faster review than standard applications.

Protocol

A document that describes the objectives, design and methods of a trial. All GLP and GCP studies must follow a protocol.

PSA   

Prostate Specific Antigen

PSUR

Periodic Safety Update Report

PSUR    

Periodic Safety Update Report (EMEA)

PT   

Proficiency Testing

PT   

Prothrombin Time

PTC

Points to Consider (Type of guidance published by FDA.)

PTCA   

Percutaneous Transluminal Coronary Angioplasty

PTCC

Pharmacology/Toxicology Coordinating Committee (CDER)

PVC   

Polyvinyl chloride

PVHO    

Pressure Vehicle for Human Occupancy (United States - ASME)

PVP    

Polyvinylpyrrolidone

QA

Quality Assurance

QA   

Quality Assurance

QC

Quality Control

QC    

Quality Control

QE   

Quality Engineer

QNS

Quantity Not Sufficient

QoL

Quality of Life

QS    

Quality System

QS   

Quality System (United States)

QSIT

Quality System Inspection Technique

QSIT   

Quality System Inspection Technique (United States - FDA)

QSR

Quality System Regulations (June 1997)

QSR   

Quality System Regulation (United States - FDA)

R&D

Research and Development

R&D   

Research and Development

R.A.C.   

Regulatory Affairs Certified

RA

Regulatory Affairs

RA    

Rheumatoid Arthritis

RA    

Regulatory Affairs

RA    

Regulatory Authority

RAC

Reviewer Affairs Committee (CDER) or Regulatory Affairs Certification

Rapporteur

Member of EU who performs initial review of centralized application.

RAPS

Regulatory Affairs Professionals Society

RAPS   

Regulatory Affairs Professionals Society

RBC   

Red Blood Cell

RBG   

Red, Blue Green

RCHSA    

Radiation Control Health and Safety Act of 1968

RCT

Randomized Clinical Trial or Randomized Controlled Trial

RCT   

Randomised Controlled Trials (Australia)

RDE

Remote Data Entry

Recall

Correction or removal of a device, drug or biologic for human use when FDA finds a reasonable probability that the product would cause serious, adverse health consequences or death.

Recall Classification

Assigned by FDA and applicable to firm-initiated recalls based on reasonable probability and relative degree of health hazard. Class I—violative device would cause serious adverse health consequences. Class II—violative device may cause temporary or medically reversible adverse health consequences or such consequences are remote. Class III—violative device is not likely to cause adverse health consequences.

REF   

Reference

Regulation

Refers to Code of Federal Regulations

RESNA    

Rehabilitation Engineering and Assistive Technology Society of North America

Restricted Device

A device, which by regulation is restricted to sale, distribution, and/or use only upon the written or oral authorization of a licensed practitioner or other conditions prescribed by the Commissioner.

RF    

Rheumatoid Factor

RF    

Radiofrequency

RFDA    

Regional Food and Drug Agencies (Korea - KFDA)

RFI   

Radiofrequency Interference (?)

RMS    

RNA    

RO    

Reverse Osmosis

RP    

Review Panel (Canada - CGSB)

RTF

Refuse To File (Letter sent by FDA when incomplete NDA or ANDA is filed. FDA will not review the application until complete.)

RUO

Research Use Only

RUO    

Research Use Only (United States - FDA)

Rx

Prescription

S&E

Safety and Efficacy

S/MIME    

Secure MIME

SAE

Serious Adverse Event

SAE    

The Society of Automotive Engineers (United States)

SAE    

The Society of Automotive Engineers, International

SAL    

Sterility Assurance Level

SAM    

State Agency for Medicines (Estonia)

SAMHSA   

Substance Abuse and Mental Health Services Administration (United States)

SAMMDRA   

South African Medicines and Medical Devices Regulatory Authority (South Africa)

SAS   

Statistical Analysis System

SAS    

Special Access Scheme (Australia)

SBA

Summary Basis of Approval

SBA   

Small Business Administration (United States)

SBOA   

Summary Basis of Approval (United States - FDA)

SBU   

Sweden's national committee on health technology assessment (Sweden)

SC

Study Coordinator

SC   

Standing Committee (United States - NCCLS)

SC    

Safety Committee (IEC)

SCAN    

Scientific Committee on Animal Nutrition (EU)

SCC   

SD

Standard Deviation

SDA   

State Drug Administration (China)

SE

Substantially Equivalent

SE   

Substantially Equivalent (United States)

SGML   

Standard Generalized Markup Language

Shelf Life

Maximum time a device will remain functional from the date of manufacture until it is used in patient care. See Expiration Date.

SIDC    

State Institute for Drug Control (Slovakia/Slovak Republic) http://www.sukl.sk/ (main homepage) http://www.sukl.sk/Sukl_sk.htm (in Slovak) http://www.sukl.sk/Sukl_en.htm (in English)

Significant Risk Device

is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health; and presents a potential for serious risk to the health, safety, or welfare of a subject.

SIP    

Sample Item Portion

SLK    

Norwegian medicines regulatory authority

SMART

Submission Management and Review Tracking

SMCA    

State Medicines Control Agency (Lithuania) http://www.vvkt.lt/Default.htm http://www.vvkt.lt/defaeng.htm (in English)

SMDA

Safe Medical Devices Act (1990)

SMDA   

Safe Medical Devices Act of 1990 (United States)

SME

Significant Medical Event

SN   

Safety Notice (UK - MDA)

SNDA

Supplemental New Drug Application

SNIP   

French pharmaceutical industry association

SNIP    

Pharmaceutical association (France)

SNITEM   

French medical devices industry association - medical devices industry association (France)

SOP

Standard Operating Procedure

SOP   

Standard Operating Procedure

Source Documents

Original documents and records containing information captured in a clinical study. Case Report Forms are monitored against the source documents. Includes office charts, laboratory results, x-rays, etc.

SPAC    

State Pharmaceutical Administration of China (China)

SPC    

Summary of Product Characteristics

SPC    

Statistical Process Control

SPC   

Supplementary Protection Certificate (CEEC Patent-related)

Special 510(k)

 for use where device modifications neither affect the intended use nor alter its fundamental scientific technology. Process time is 30 days.

Sponsor

A company, person, organization or institution that takes responsibility for initiating, managing or financing a clinical trial.

Spri    

Swedish Institute for Health Services Development

SQL    

Structured Query Language

SR

Significant Risk

SRM    

(Australia)

SRM   

Specified Risk Materials (EU)

SSE   

Summary of Safety and Effectiveness (US - FDA)

Standard Review (S)

FDA review category for drugs with therapeutic qualities similar to those already approved for marketing.

STMP   

Simple Mail Transfer Protocol

STS   

Society of Thoracic Surgeons (US)

Subject

A participant in a clinical trial. May be a healthy volunteer or a patient.

Subpart E

21 CFR 312: Accelerated review for life threatening and severely debilitating illness

Subpart H

21 CFR 314.500: Approval based on a surrogate endpoint or a product approved with restrictions and/or requirements for Phase IV trials.

Substantial Equivalence

Comparison of a new device to a legally marketed predicate device, substantial equivalence establishes safety and effectiveness.

SÚKL   

State Institute for Drug Control (Czech Republic)

SUPAC

Scale Up and Post Approval Changes

SUPAC   

Scale-up and Post Approval Changes (US FDA)

Supplement (sNDA)

NDA submission for changes to an approved NDA, including SUPAC.

Supplement (sPMA)

PMA submission for changes to an approved PMA that affect the safety or effectiveness of the device.

Surrogate Endpoint

Indirect measure of outcome that is easier to measure and relates to outcome of interest.

SVS    

Society for Vascular Surgery

SVS    

Danish National Veterinary Laboratory

SYSBASE   

TABD    

TAC    

Technical Advisory Committee (Canada - CGSB)

TAG    

(IEC)

TC    

Technical Committee

TCP/IP   

Transfer Control Protocol/Internet Protocol

TEC    

Technology Evaluation Center (US - Blue Cross/Blue Shield Association)

TEMPLAR   

TEP    

Transatlantic Economic Partnership

TEPRSSC    

Technical Electronic Products Radiation Safety Standards Committee (United States - FDA)

TESS

Treatment Emergent Signs and Symptoms

TGA   

Therapeutic Goods Administration (Australia) http://www.health.gov.au/tga/

TGO    

Therapeutic Goods Order (Australia)

TIFF    

Tag Image File Format (a CCITT standard for electronically storing images)

TIPPSA    

Technical Industrial Pharmacists and Pharmaceutical Scientists Association http://www.lowwwe.com/tippsa/

TIPS    

French private healthcare sector evaluation and product pricing system (France)

TIPS   

Interministériel des presentations sanitaires (France)

TK

Toxicokinetics

TLV    

Threshold Limit Values

TMJ   

Tempromandibular Joint Prosthesis

TMR   

Transmyocardial revascularization

TOC    

Table of Contents

TPD    

Therapeutic Products Directorate (Canada)

TPP    

Therapeutic Products Program (Canada)

TPR   

True Positive Rate

Treatment IND (tIND)

Allows limited use of an unapproved drug for patients with a serious or life-threatening disease.

TSE   

Transmissible Spongiform Encephalopathy

TUMT   

Transurethral Microwave Therotherapy

UHMS   

Undersea and Hyperbaric Medical Society (United States)

UL    

Underwriters Laboratory (United States)

UMA    

Urgent Message Application (ETOMEP) http://www.jrc.org/isis/etomep/activities/index.asp#s02

UMDNS    

Universal Medical Device Nomenclature

UNAMEC   

Belgian medical device industry association (Belgium)

UNEC   

United Nations Economic Commission for Europe

Unexpected AE

An AE whose nature or severity is not described in the Investigator’s Brochure (for an unapproved product) or in the package insert (for an approved product).

USAN

United States Adopted Name

USC

United States Code

USC   

United States Code (United States)

USC    

United States Code (United States)

USCA

US Code Annotated

USDA

United States Department of Agriculture

User Fees

Fees used by FDA to expedite review time. The fee schedule for different types of applications is published in the Federal Register. Initially established by the 1992 Prescription Drug User Fee Act.

USP

US Pharmacopeia

USP   

United States Pharmacopeia (United States)

USP/NF    

United States Pharmacopeia/National Formulary (United States)

USR    

Urgent Safety Restriction (EMEA)

USUHS

Uniformed Services University of the Health Sciences

UV   

Ultraviolet

VA

United States Department of Veterans Affairs

VAERS

Vaccine Adverse Event Reporting System

VAERS    

VAI

Voluntary Action Indicated (indicated on FDA Form 483 following an inspection)

VAN   

Virtual Area Network

VBR    

(Netherlands)

VFA   

Association of research-based pharmaceutical companies in Germany

VICH   

International Cooperation on Harmonisation of Technical Requirements for the Registration of Veterinary Medicinal Products

VMD    

Veterinary Medicines Directorate (United Kingdom)

VMF   

Veterinary Master File

VP   

Validation Plan

VP   

Validation Protocol

WAN   

Wide Area Network

Warning Letter (WL)

Most serious post-audit letter, requires immediate action within 15 days.

WBC   

White Blood Cell

WEAC    

(US - FDA - CDRH)

Well-Characterized

Refers to well-defined biologics that formerly were the only ones filed with a BLA.

WG   

Working Group (IEC)

WHO

World Health Organization

WHO   

World Health Organization

WHOART

Adverse Reaction Terms, developed by WHO, used to code AE’s to standard preferred terms and body systems. Will be replaced by MedDRA.

WWW   

World Wide Web

Y2K   

Year 2000