LEADER 02578nam 2200577Ia 450 001 9910819115603321 005 20240417003942.0 010 $a0-309-17944-0 010 $a1-281-09355-6 010 $a9786611093556 010 $a0-309-10987-6 035 $a(CKB)1000000000479984 035 $a(SSID)ssj0000119589 035 $a(PQKBManifestationID)11133336 035 $a(PQKBTitleCode)TC0000119589 035 $a(PQKBWorkID)10058841 035 $a(PQKB)10675648 035 $a(MiAaPQ)EBC3378297 035 $a(Au-PeEL)EBL3378297 035 $a(CaPaEBR)ebr10197081 035 $a(OCoLC)923277608 035 $a(EXLCZ)991000000000479984 100 $a20071102d2007 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 10$aChallenges for the FDA $ethe future of drug safety : workshop summary /$fForum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Leslie Pray and Sally Robinson, rapporteurs 205 $a1st ed. 210 $aWashington, DC $cNational Academies Press$dc2007 215 $axvii, 109 p. $cill 300 $aBibliographic Level Mode of Issuance: Monograph 311 $a0-309-10986-8 320 $aIncludes bibliographical references (p. 78-79). 327 $aFrontMatter -- 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. 606 $aDrugs$zUnited States$xTesting$vCongresses 606 $aDrugs$zUnited States$xSafety measures$vCongresses 615 0$aDrugs$xTesting 615 0$aDrugs$xSafety measures 701 $aPray$b Leslie A$0880793 701 $aRobinson$b Sally$0620917 712 02$aInstitute of Medicine (U.S.).$bForum on Drug Discovery, Development, and Translation. 712 12$aSymposium on the Future of Drug Safety: Challenges for the FDA 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910819115603321 996 $aChallenges for the FDA$93967490 997 $aUNINA