FDA-speak : a glossary and agency guide PDF
Preview FDA-speak : a glossary and agency guide
FDA-SPEAK A Glossary and Agency Guide Edited by Dean E. Snyder CopyrightedMaterial CopyrightedMaterial CopyrightedMaterial FDA-SPEAK A Glossary and Agency Guide Edited by Dean E. Snyder ~.~i,")· '1W : ,," IHSHealth GroupN AnI6fiR011JCompony Denver, Colorado CopyrightedMaterial InvitationtoAuthors ,....c: ~ ll-IS®HealthGrouppublishesbooksfocuseduponappliedtech- ~ ~ ~ nologyandregulatoryaffairsimpactinghealthcaremanufactur- ~~::::?= ersworldwide.Ifyouareconsideringwritingorcontributingto ~ abookapplicabletothepharmaceutical,biotechnology,medical device, diagnostic, cosmetic, or veterinary medicine manufacturing industries, 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 Copyright©2002byIHS®HealthGroup.Allrightsreserved. All rights reserved. This book is protected by copyright. No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without writtenpermissionfrom thepublisher. Printedin theUnitedStatesofAmerica. Where a product trademark, registration mark, or other protected mark is made in the text, ownership of the mark remains with the lawful owner of the mark. Noclaim,intentionalorotherwise,ismadebyreferencetoanysuchmarks in thisbook. Whileevery effort hasbeen made by IHS®HealthGroup to ensure the accu racy of the information contained in this book, this organization accepts no responsibilityfor errorsoromissions. IHS®HealthGroup Phone: +1-303-662-9101 15InvernessWayEast Fax: +1-303-754-3953 Englewood,CO80112-5776,USA Orders/on-linecatalog: www.ihshealthgroup.com CopyrightedMaterial 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. CopyrightedMaterial 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) CopyrightedMaterial 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 Copyrighted Material 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. CopyrightedMaterial vi
The list of books you might like
