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terms and acronyms

Quiz yourself by thinking what should be in each of the black spaces below before clicking on it to display the answer.
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Question
Answer
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  


   






 
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