TAILIEUCHUNG - Safe and Effective Medicines for Children: Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

Children, in general, are healthier than their adult counterparts, particularly as adults reach the fifth decade of life and beyond. However, children do have multiple acute illnesses each year, and a substantial number of children, often estimated to be 20 percent or more, are burdened with chronic health disorders, some of them disabling or life threatening. Medical attention, including evidence-based prescription of drugs or biologics, is vital for their well-being. In addition, children constitute a smaller percentage of the United States population than adults, so drugs are often designed for adults and initially tested and approved for use in adult populations. Clinicians, however, often begin to use these drugs—as. | Safe and Effective Medicines for Children Pediatric Studies Conducted Under the Best Pharmaceuticals for NATIONAL RESEARCH COUNCIL Or rm ACAD M S Safe and Effective Medicines for Children Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act BPCA and the Pediatric Research Equity Act PREA Board on Health Sciences Policy Marilyn J. Field and Thomas F. Boat Editors INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington. . WWW. na u THE NATIONAL ACADEMIES PRESS 500 Fifth Street . Washington DC 20001 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. DHHS-8598 TO 16 between the National Academy of Sciences and the Food and Drug Administration . Department of Health and Human Services. Any opinions findings conclusions or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number prepublication 978-0-309-22549-6 International Standard Book Number prepublication Library of Congress Cataloging-in-Publication Data Additional copies of this report are available from the National Academies Press 500 Fifth Street . Lockbox 285 Washington DC 20055 800 624-6242 or 202 334-3313 in the Washington metropolitan area Internet http . For more information about the Institute of Medicine visit the IOM home page at . .

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