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Building a national framework for the establishment of regulatory science for drug development : workshop summary / Institute of Medicine of the National Academies ; Yeonwoo Lebovitz, Rebecca A. English, and Anne B. Claiborne, rapporteurs.
- Format:
- Book
- Conference/Event
- Author/Creator:
- Institute of Medicine (U.S.).
- Conference Name:
- Building a National Framework for the Establishment of Regulatory Science for Drug Development (2010 : Washington, D.C.)
- Language:
- English
- Subjects (All):
- Pharmaceutical policy--United States--Congresses.
- Pharmaceutical policy.
- Drug development--Government policy--United States--Congresses.
- Drug development.
- Pharmaceutical industry--Government policy--United States--Congresses.
- Pharmaceutical industry.
- Physical Description:
- 1 online resource (95 pages)
- Edition:
- First edition.
- Place of Publication:
- Washington, D.C. : National Academies Press, 2011.
- Language Note:
- English
- 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.
- Contents:
- ""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""
- Notes:
- "Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy."
- Includes bibliographical references.
- ISBN:
- 0-309-20959-5
- 1-283-01910-8
- 9786613019103
- 0-309-15890-7
- OCLC:
- 923283190
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