FDA-speak : a glossary and agency guide

376 Pages·2002·6.17 MB·English

by  Dean E Snyder

FDA-SPEAK
A Glossary and Agency Guide
Edited by Dean E. Snyder
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FDA-SPEAK
A Glossary and
Agency Guide
Edited by
Dean E. Snyder
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IHSHealth GroupN
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Denver, Colorado
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InvitationtoAuthors
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pleasecontactourdirectorofpublications.
LibraryofCongressCataloging-in-PublicationData
FDAspeak:aglossaryandagency guide / editedbyDeanE. Snyder.-2nded.
p.cm.
ISBN1-57491-129-5
1. UnitedStatesFoodandDrugAdministration-Acronyms. 2. United
StatesFoodandDrugAdministration-Terminology. I. Snyder,DeanE.
RA11 .B182002
353.9'98'0973-<1c21
2001051908
Interiordesignand typesettingbykalzubdesign.
10 9 8 7 6 5 4 3 2 1
ISBN: 1-57491-129-5
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iii
TolearnmoreaboutvariousaspectoftheFDA'shistory,visitthe"FDAHistory"
Webpage,reproducedbelow,athttp://www.fda.gov/opacom/7history.html.
Thepagecontainslinkstofull-textversionsofthedocumentslisted.
U.S.FoodandDrugAdministration
FDA History
• MilestonesinFDAHistory
• The Rise and FallofFederalFoodStandardsinthe United
States: TheCase ofthePeanutButterand Jelly Sandwich
• HistoryofFDAand theCenterfor Food Safetyand
Applied Nutrition
• ABriefHistoryoftheCenterfor DrugEvaluationand
Research
• Commissioners and TheirPredecessors-TermsofOffice
• DeputyCommissionersand TheirPredecessors -Termsof
Office
• ShortBiographies ofFDACommissioners and Their
Predecessors
• Designationand LocationofFDAinthe Federal
Government
• SelectedSourcesonthe HistoryofFDA(bibliography)
FDAHomePage ISearch IA-ZIndex ISiteMap IContactFDA
FDA/WebsiteManagementStaff
Webpageupdatedbytg2001-APR-16.
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iv
TheFDA'sMissionstatementisreproducedhereasitappearsontheFDAWeb
site.YoucanvisitthisWebpageathttp://www.fda.gov/opacomlmore
choicesImission.html.
U.S.Foodand DrugAdministration
FDA's Mission
TheFDAModernizationActof1997(PL105-115)affirmed FDA's public
healthprotectionroleand defined theAgency's mission:
1. To promote the publichealthbypromptlyandefficientlyreviewing
clinicalresearchand takingappropriate actiononthe marketingof
regulatedproductsina timely manner;
2. Withrespect to suchproducts, protectthepublichealthbyensur
ing thatfoods aresafe,wholesome, sanitary, andproperlylabeled;
humanandveterinarydrugs are safeandeffective; there is reason
able assuranceofthesafetyand effectiveness ofdevicesintended
for human use;cosmeticsaresafeandproperlylabeled,and; public
healthandsafetyareprotectedfrom electronicproductradiation;
3. Participatethroughappropriateprocesseswithrepresentatives of
othercountries to reduce theburdenofregulation, harmonizereg
ulatoryrequirements,andachieveappropriate reciprocalarrange
ments;and,
4. Asdetermined tobeappropriatebytheSecretary, carryoutpara
graphs (1) through(3) inconsultationwithexpertsinscience, med
icine,and publichealth, and incooperationwithconsumers, users,
manufacturers,importers, packers, distributorsand retailers ofreg
ulated products.
(hypertext updatedbyjch 1998-0CT-19)
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Contents
Introduction vi
Glossary 1
Appendix A 269
Appendix B 272
Appendix C 277
Appendix D 281
Appendix E 284
Appendix F 285
Appendix G 287
Appendix H 311
Appendix I 325
Appendix J 329
Appendix K 339
Appendix L 354
Appendix M 356
Acknowledgments 361
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Introduction
InthenineyearssincethefirsteditionofFDA-SPEAKwaspublished,innovations
in the use of computers and computer software have invaded every aspect of
manufacturing,control,distribution,and saleofdrugsandmedicaldevices. The
jargonassociatedwithcomputers andsoftware;new regulations, includingnew
definitionsofdietaryandfoodsupplements;newclearancepathwaysformedical
devices; and the FDA's use of the Internet to publish its regulations and guid
anceshavecreatedtheneedfor asecondedition.
Dozensofcomputertermsareincludedthatarecommonplacetoday,butwere
known only within the software fraternity nine years ago. Because of the wide
spread use of computers and software to control manufacturing of drugs and
devices,theFDAhasforsometimeemphasizedvalidationandverificationofcom
putersoftware.Biotechnologyproductsarenowjustadditionalmarketedproducts,
comparedtotheirstatusasrevolutionaryscientificachievementsnineyearsago.
New sources for definitions include the FDA's Regulatory Procedures
Manual,theCDERDataStandardsManual,CompliancePolicyGuides,FDAMA,
the Biotechnology InspectionGuide Reference Materialsand TrainingAids, and
Import,Export,andCustomsGuidances. Wheneverpossible,citationstotheref
erenceare included. BecauseoftheFDA'suseofthe Internettopublishmaterial
that was not easily accessible previously and the existence of numerous useful
Web pages (a term notaround nine years ago), we have included references to
manyusefulWebpageswithannotationsdescribing theircontents.
FDA-SPEAKisintendedasaresourceforregulatoryprofessionals,aswellas
for thosewhoencounterregulatorymatterslessoften.Qualitycontrol,manufac
turing, research and developmentpersonnel, and administrative staffpersonnel
shouldallfind FDA-SPEAKuseful.
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