02608nam 2200589Ia 450 991097421960332120251017110132.00-309-17944-01-281-09355-697866110935560-309-10987-6(CKB)1000000000479984(SSID)ssj0000119589(PQKBManifestationID)11133336(PQKBTitleCode)TC0000119589(PQKBWorkID)10058841(PQKB)10675648(MiAaPQ)EBC3378297(Au-PeEL)EBL3378297(CaPaEBR)ebr10197081(OCoLC)923277608(DNLM)1322122(EXLCZ)99100000000047998420071102d2007 uy 0engurcn|||||||||txtccrChallenges for the FDA the future of drug safety : workshop summary /Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Leslie Pray and Sally Robinson, rapporteurs1st ed.Washington, DC National Academies Pressc2007xvii, 109 p. illBibliographic Level Mode of Issuance: Monograph0-309-10986-8 Includes bibliographical references (p. 78-79).FrontMatter -- Reviewers -- Preface -- Contents -- Tables, Figures, and Boxes -- Summary -- 1 Introduction -- 2 Addressing the FDA's Resource Challenges -- 3 Strengthening the Scientific Base of the Agency -- 4 Integrating Pre- and Postmarket Review -- 5 Enhancing Postmarket Safety Monitoring -- 6 Conducting Confirmatory Drug Safety and Efficacy Studies -- 7 Enhancing the Value of Clinical Trial Registration -- 8 Enhancing Postmarket Regulation and Enforcement -- 9 Looking to the Future -- References -- Appendixes -- Appendix A Workshop Agenda -- Appendix B Speaker Biographies.DrugsUnited StatesTestingCongressesDrugsUnited StatesSafety measuresCongressesDrugsTestingDrugsSafety measuresPray Leslie A880793Robinson Sally620917Institute of Medicine (U.S.).Forum on Drug Discovery, Development, and Translation.Symposium on the Future of Drug Safety: Challenges for the FDAMiAaPQMiAaPQMiAaPQBOOK9910974219603321Challenges for the FDA4446941UNINA