03580nam 2200673 a 450 991082831950332120240426171921.00-309-20959-51-283-01910-897866130191030-309-15890-7(CKB)2550000000032026(EBL)3378748(SSID)ssj0000507437(PQKBManifestationID)11344055(PQKBTitleCode)TC0000507437(PQKBWorkID)10562131(PQKB)10436788(MiAaPQ)EBC3378748(Au-PeEL)EBL3378748(CaPaEBR)ebr10454969(CaONFJC)MIL301910(OCoLC)923283190(EXLCZ)99255000000003202620110414d2011 uy 0engurcn|||||||||txtrdacontentcrdamediacrrdacarrierBuilding a national framework for the establishment of regulatory science for drug development[electronic resource] workshop summary /Institute of Medicine of the National Academies ; Yeonwoo Lebovitz, Rebecca A. English, and Anne B. Claiborne, rapporteursFirst edition.Washington, D.C. :National Academies Press,2011.1 online resource (95 pages)"Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy."0-309-15889-3 Includes bibliographical references.""Front Matter""; ""Reviewers""; ""Contents""; ""Figures and Boxes""; ""Acronyms""; ""Preface""; ""1 Introduction""; ""2 Defining Regulatory Science""; ""3 The Urgent Need for Regulatory Science""; ""4 Barriers to Enhanced Regulatory Science""; ""5 Potential Models for Building a Regulatory Science Infrastructure""; ""6 Challenges in Engaging the Public Policy Community""; ""7 Envisioning Successful Regulatory Science at FDA""; ""8 Considering Next Steps""; ""References""; ""Appendix A: Agenda""; ""Appendix B: Participant Biographies"""The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it."--Publisher's description.Pharmaceutical policyUnited StatesCongressesDrug developmentGovernment policyUnited StatesCongressesPharmaceutical industryGovernment policyUnited StatesCongressesPharmaceutical policyDrug developmentGovernment policyPharmaceutical industryGovernment policy615.1Lebovitz Yeonwoo1635709English Rebecca A1602351Claiborne Anne B1601264Institute of Medicine (U.S.).Forum on Drug Discovery, Development, and Translation.Institute of Medicine (U.S.).Board on Health Sciences Policy.Building a National Framework for the Establishment of Regulatory Science for Drug Development(2010 :Washington, D.C.)MiAaPQMiAaPQMiAaPQBOOK9910828319503321Building a national framework for the establishment of regulatory science for drug development3976644UNINA