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Med. Terms and Ac

terms and acronyms

QuestionAnswer
Expiration Date Date printed on a product label indicating the end of the product's useful life.
EU European Union which has 27 member states
FAR Field Alert Report
Fast Track FDA program to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs.
FCC Federal Communications Commission
FD&C ACT(FDCA) Federal Food, Drug & Cosmetic Act
FDA Food and Drug Administration
FDAMA FDA Modernization Act of 1997
FDERA Food and Drug Export reform and enchancement act of 1996
FDLI food and drug law institute
FMECA failure mode, effects and critical analysis
FOIA freedom of information act
FPLA fair packaging and labeling act
FR federal regulations
GAO GENERAL ACCOUNTING OFFICE
FTC FEDERAL TRADE COMMISSION
GATT GENERAL AGREEMENT OF TARIFFS AND TRADE
GCP GOOD CLINICAL PRACTICE. REGULATION AND REQUIREMENTS WITH WHICH CLINICAL STUDIES MUST COMPLY
GENERIC DRUG DRUGS MANUFACTURED AND APPROVED AFTER THE ORIGINAL BRAND NAME DRUG HAS LOST PATENT PROTECTION.
GGP GOOD GUIDANCE PRACTICE
GLP GOOD LABORATORY PRACTICE.
GMP GOOD MANUFACTURING PRACTICE (FOR DEVICES, SEE QUALITY SYSTEM REGULATIONS 1997).
GRANDFATHERED TACIT APPROVAL OD DRUGS MARKETED BEFORE 1938 AND DEVICES MARKETED BEFORE MAY 1976.
GRAS(E) GENERALLY RECOGNIZED AS SAFE (AND EFFECTIVE)
GRP GOOD REVIEW PRACTICE
GUIDANCE DOCUMENTS PUBLISHED BY FDA TO PROVIDE CURRENT INTERPRETATION OF REGULATIONS
HAACP HAZARD ANALYSIS AND CRITICAL CONTROL POINT (INSPECTION TECHNIQUE)
HCFA HEALTH CARE FINANCING ADMINISTRATION (DETERMINES MEDICARE PAYMENT SYSTEM)
HDE HUMANITARIAN DEVICE EXEMPTION
HMO HEALTH MAINTENANCE ORGANIZATION
HPB HEALTH PROTECTION BRANCH (CANADA'S EQUIVALENT OF FDA)
HUD HUMANITARIAN USE DEVICE
IB INVESTIGATOR'S BROCHURE
IC (ICF) INFORMED CONSENT (FORM)
ICH INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
IDE INVESTIGATIONAL DEVICE EXEMPTION
IDMC INDEPENDENT DATA MONITORING COMMITTEE
IDSMB INDEPENDENT DATA SAFETY MONITORING BOARD
INACTIVE INGREDIENT ANY DRUG PRODUCT COMPONENT OTHER THAN THE ACTIVE INGREDIENT, SUCH AS EXCIPIENT, VEHICLE AND BINDERS
INAD INVESTIGATIONAL NEW ANIMAL DRUG
IND INVESTIGATIONAL NEW DRUG (APPLICATION)
INFORMATION AMENDMENT INCLUDES MOST SUBMISSIONS UNDER AN ACTIVE IND, SUCH AS NEW PROTOCOLS, FINAL STUDY REPORTS, SAFETY REPORTS, CMC INFORMATION, ETC.
INN INTERNATIONAL NONPROPRIETARY NAMES
INTENDED USE OBJECTIVE LABELED USE OF A DEVICE
INVESTIGATOR IND PROTOCOL AND IND SUBMITTED BY AN INDIVIDUAL INVESTIGATOR INSTEAD OF A MANUFACTURER.
IRB INSTITUTIONAL REVIEW BOARD OR INDEPENDENT REVIEW BOARD
ISO INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (NOT AN ACRONYM)
ISPE INTERNATIONAL SOCIETY OF PHARMACEUTICAL ENGINEERING; INTERNATIONAL SOCIETY OF PHARMACOEPIDEMIOLOGY
IUO INVESTIGATIONAL USE ONLY
IVDD IN VITRO DIAGNOSTIC
IVDD IN-VITRO DIAGNOSTIC DEVICE DIRECTIVE
JMHW JAPANESE MINISTRY OF HEALTH AND WELFARE
LABEL ANY DISPLAY OF WRITTEN, PRINTED OR GRAPHIC MATTER ON THE IMMEDIATE CONTAINER OR PACKAGE OD, 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
LOA LETTER OF AUTHORIZATION
MA MARKETING AUTHORIZATION
MACEAC MAXIMUM ALLOWABLE COST-ESTIMATED ACQUISITION COST
MARKET WITHDRAWL FIRM INITIATED REMOVAL OR CORRECTION OF A DEVICE, DRUG, OR BIOLOGIC PRODUCT INVOLVING A MINOR VIOLATION OF THE FD&C ACT, NOT SUBJECT TO LEGAL ACTION BY FDA
MAPP MANUEL OF POLICY AND PROCEDURES
MDD MEDICAL DEVICE DIRECTIVE (EU)
MDR MEDICAL DEVICE REPORT
MDUFMA MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002
MEDICAL DEVICE ANY INSTRUMENT, APPARATUS, IMPLEMENT, MACHINE, CONSTRIVANCE, IMPLANT, IN VITRO REAGENT, OR OTHER SIMILAR OR RELATED ARTICLE, INCLUDING ANY COMPONENT, PART OR ACCESSORY THAT IS INTENDED FOR USE IN DIAGNOSIS OR OTHER CONDITIONS OR TREATMENT OR PREVENTION
Created by: keke.d@Wiz.86