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Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. Emerging Safety Science: Workshop Summary. Washington (DC): National Academies Press (US); 2008.

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Emerging Safety Science: Workshop Summary.

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This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report:

C. Thomas Caskey, University of Texas Health Science Center at Houston

Joseph M. Feczko, Pfizer, Inc.

Stephen Groft, Office of Rare Disease Research, National Institutes of Health

Patrice M. Milos, Helicos BioSciences Corporation

Joanne L. Rhoads, National Institute of Allergy and Infectious Diseases (retired)

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Hellen Gelband, Scholar-in-Residence, Institute of Medicine. Appointed by the Institute of Medicine, she was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authors and the institution.


In addition to our reviewers, we would like to especially thank members of the U.S. Food and Drug Administration (FDA) staff who provided assistance in the development of the workshop concept and agenda. They include Daryl Allis, Rachel Behrman, Howard Chazin, Lois Chester, Charles Cooper, Gerald Dal Pan, Felix Frueh, Steven Galson, Federico Goodsaid, David Jacobson-Kram, John Jenkins, Jan Johannessen, Elizabeth Mansfield, Robert Meyer, Shirley Murphy, Judith A. Racoosin, George Rochester, Wendy Sanhai, Paul Seligman, Judy Staffa, Ana Szarfman, Ellis Unger, Keith Webber, and Janet Woodcock.

Copyright © 2008, National Academy of Sciences.
Bookshelf ID: NBK4044


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