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