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200 10$aBuilding a national framework for the establishment of regulatory science for drug development $eworkshop summary /$fInstitute of Medicine of the National Academies ; Yeonwoo Lebovitz, Rebecca A. English, and Anne B. Claiborne, rapporteurs
205   $aFirst edition.
210   $aWashington, D.C. $cNational Academies Press$d2011
215   $a1 online resource (95 pages)
300   $a"Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy."
311   $a0-309-15889-3 
320   $aIncludes bibliographical references.
327   $a""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""
330   $a"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.
606   $aPharmaceutical policy$zUnited States$vCongresses
606   $aDrug development$xGovernment policy$zUnited States$vCongresses
606   $aPharmaceutical industry$xGovernment policy$zUnited States$vCongresses
615  0$aPharmaceutical policy
615  0$aDrug development$xGovernment policy
615  0$aPharmaceutical industry$xGovernment policy
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701   $aLebovitz$b Yeonwoo$01635709
701   $aEnglish$b Rebecca A$01602351
701   $aClaiborne$b Anne B$01601264
712 02$aInstitute of Medicine (U.S.).$bForum on Drug Discovery, Development, and Translation.
712 02$aInstitute of Medicine (U.S.).$bBoard on Health Sciences Policy.
712 12$aBuilding a National Framework for the Establishment of Regulatory Science for Drug Development$f(2010 :$eWashington, D.C.)
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