TAILIEUCHUNG - The Acquisition of Drugs and Biologics for Chemical and Biological Warfare Defense - Department of Defense Interactions with the Food and Drug Administration

However, these events are but the immediate manifestation of a continuing dependent relationship that involves three types of interactions: licensing CBW drugs and biologics, especially vaccines; using Investigational New Drugs in military combat (and other special situations); and ensuring the compliance of producers with manufacturing requirements. DoD has not been well organized to respond to FDA. This report proposes various education and training programs that should be initiated for all defense personnel engaged in the development or acquisition of drugs and biologics for CBW defense. It also recommends organiza. | The Acquisition of Drugs and Biologics for Chemical and Biological Warfare Defense Department of Defense Interactions with the Food and Drug Administration Richard A. Rettig Jennifer Brower with Orlie Yaniv Prepared for the Office of the Secretary of Defense National Defense Research Institute I RAND Health RAND Approved for public release distribution unlimited The research described in this report was sponsored by the Office of the Secretary of Defense OSD . The research was conducted jointly by RAND Health s Center for Military Health Policy Research and the Forces and Resources Policy Center of the National Defense Research Institute a federally funded research and development center supported by the OSD the Joint Staff the unified commands and the defense agencies under Contract DASW01-01-C-0004. Library of Congress Cataloging-in-Publication Data Rettig Richard A. The acquisition of drug and biologics for chemical and biological warfare defense Department of Defense interactions with the Food and Drug Administration Richard A. Rettig Jennifer Brower with Orlie Yaniv. p. cm. Mr-1659. Includes bibliographical references and index. ISBN 0-8330-3450-2 pbk. 1. Chemical agents Munitions Safety measures. 2. Biological weapons Safety measures. 3. United States Armed Forces Medical supplies. 4. United States. Dept. of Defense Procurement. 5. United States. Food and Drug Administration. I. Brower Jennifer 1967- II. Yaniv Orlie. . 2003 358 .34 0973 dc22 2003015371 RAND is a nonprofit institution that helps improve policy and decisionmaking through research and analysis. RAND is a registered trademark. RAND s publications do not necessarily reflect the opinions or policies of its research sponsors. Copyright 2003 RAND All rights reserved. No part of this book may be reproduced in any form by any electronic or mechanical means including photocopying recording or information storage and retrieval without permission in writing from RAND. Published 2003 .

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• High throughput
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