Title Building a national framework for the establishment of regulatory science for drug development : workshop summary / Yeonwoo Lebovitz, Rebecca A. English and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies

Published Washington, D.C. : National Academies Press, ©2011

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Description 1 online resource (xvi, 78 pages) : color illustrations Contents Introduction -- Defining regulatory sciences -- The urgent need for regulatory science -- Barriers to enhanced regulatory science -- Potential models for building a regulatory science infrastructure -- Challenges in engaging the public policy community -- Envisioning successsful regulatory science at FDA -- Considering next steps Summary "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 Bibliography Includes bibliographical references (pages 53-55) Notes English Print version record Subject United States. Food and Drug Administration. SUBJECT United States. Food and Drug Administration fast Subject Drug development -- United States -- Congresses Drug Discovery Clinical Trials as Topic Drug Approval Drug Evaluation POLITICAL SCIENCE -- Government -- State & Provincial. Drug development SUBJECT United States https://id.nlm.nih.gov/mesh/D014481 Subject United States Genre/Form proceedings (reports) Conference papers and proceedings Conference papers and proceedings. Actes de congrès. Form Electronic book Author Lebovitz, Yeonwoo English, Rebecca A Claiborne, Anne B Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation. ISBN 9780309158909 0309158907 1283019108 9781283019101 9786613019103 6613019100

Other Titles Regulatory science for drug development Forum on Drug Discovery, Development, and Translation

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