Title 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 Equality Act (PREA), Institute of Medicine of the National Academies ; edited by Marilyn J. Field and Thomas F. Boat

Published Washington, D.C. : National Academies Press, 2012

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Description 1 online resource (xxiii, 408 pages) : illustrations (some color) Contents Introduction -- Children's growth and development and pediatric drug studies -- Policy framework for BPCA and PREA -- Ethical issues in pediatric drug studies -- Safety and efficacy assessment in studies conducted under BPCA and PREA -- BPCA, PREA, and drug studies with neonates -- Outcomes of written requests, requirements, studies, and labelling changes -- Pediatric studies of biologics Summary "The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children"--Publisher's description Bibliography Includes bibliographical references and index Notes Print version record Subject Pediatric pharmacology -- Research -- United States Pediatric pharmacology -- Law and legislation -- United States Drugs -- United States -- Testing Pediatrics. Drugs. Child Health Services -- legislation & jurisprudence Drug Approval -- legislation & jurisprudence Drug Industry -- legislation & jurisprudence Drug Labeling -- legislation & jurisprudence Legislation, Drug Patents as Topic -- legislation & jurisprudence Pediatrics Pharmaceutical Preparations MEDICAL -- Pharmacology. Pediatrics Drugs Drugs -- Testing United States Form Electronic book Author Field, Marilyn J. (Marilyn Jane) Boat, Thomas F. Institute of Medicine (U.S.). Committee on Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equality Act (PREA) Institute of Medicine (U.S.). Board on Health Sciences Policy ISBN 0309225507 9780309225502 6613948802 9786613948809

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