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Cover of Building a National Framework for the Establishment of Regulatory Science for Drug Development

Building a National Framework for the Establishment of Regulatory Science for Drug Development

Workshop Summary


Washington (DC): National Academies Press (US); .
ISBN-13: 978-0-309-15889-3ISBN-10: 0-309-15889-3


The public increasingly recognizes the importance of regulatory science. The notion of basing regulatory decisions on the best scientific knowledge available is not new, but never before have funds been deliberately appropriated for the accomplishment of this task. The Food and Drug Administration's (FDA) 2011 budget proposal includes $25 million specifically allocated to the building of a regulatory science infrastructure at the agency. In anticipation of this event and as an acknowledgment of the “reform-ready” political atmosphere, the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation held a public workshop with the following goals in mind:

  • Establish a clear definition of regulatory science, and engage the public and the policy community in a discussion of its challenges and opportunities.
  • Increase awareness of inadequate funding for regulatory science and the impact on the development of new therapies on patients.
  • Articulate priorities and strategies for building or rebuilding the infrastructure for regulatory science.


Rapporteurs: Yeonwoo Lebovitz, Rebecca A English, and Anne B Claiborne

This project was supported by the Department of Health and Human Services (Contract Nos. N01-OD-4-2139 and 223001003T), the American Diabetes Association, the American Society for Microbiology, Amgen Inc., the Association of American Medical Colleges, Bristol-Myers Squibb, the Burroughs Wellcome Fund, Celtic Therapeutics, LLLP, the Critical Path Institute, the Doris Duke Charitable Foundation, Eli Lilly & Co., GlaxoSmithKline, Johnson & Johnson, Novartis Pharmaceuticals Corporation, and Pfizer, Inc.

Suggested citation:

IOM (Institute of Medicine). 2011. Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington, DC: The National Academies Press.

Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

Copyright © 2011, National Academy of Sciences.
Bookshelf ID: NBK54404PMID: 21595117
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