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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. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This study was supported by Contract No. 223-01-2460, Task Order No. 23; HHSP23320042509XI, Task Order No. 3; and HHSM-500-2005-00026C between the National Academy of Sciences and the Department of Health and Human Services (the Food and Drug Administration, the Agency for Healthcare Research and Quality, the Centers for Medicaid and Medicare Services, the National Institutes of Health), and the United States Department of Veterans Affairs. 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.

Library of Congress Cataloging-in-Publication Data

Institute of Medicine (U.S.). Committee on the Assessment of the US Drug Safety System.

The future of drug safety : promoting and protecting the health of the public / Committee on the Assessment of the US Drug Safety System, Board on Population Health and Public Health Practice ; Alina Baciu, Kathleen Stratton, Sheila P. Burke, editors.

p. ; cm.

Includes bibliographical references.

ISBN 978-0-309-10304-6 (pbk.)

1. Pharmaceutical policy—United States. 2. United States. Food and Drug Administration. 3. Drugs—Safety measures—United States. I. Baciu, Alina. II. Stratton, Kathleen R. III. Burke, Sheila P. IV. Title.

[DNLM: 1. United States. Food and Drug Administration. 2. Drug Approval—United States. 3. United States Government Agencies—United States. QV 771 I5852f 2007]

RA401.A3.I568 2007

362.17′82—dc22

2006039224

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Copyright 2007 by the National Academy of Sciences. All rights reserved.

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