Safe and effective medicines for children pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

• Corporate Author: National Research Council (U.S.)
• Other Authors: Field, Marilyn J. (Marilyn Jane) (Editor), Boat, Thomas F. (Editor)
• Format: Book
• Language: English
• Published: Washington, D.C. National Academies Press 2012
• Subjects: Clinical Trials as Topic > Congress > legislation & jurisprudence > United States; Clinical Trials as Topic > Congress > standards > United States; Adolescent > Congress > United States; Child > Congress > United States; Drug Approval > Congress > legislation & jurisprudence > United States; Drug Evaluation > Congress > legislation & jurisprudence > United States; Drug Industry > Congress > legislation & jurisprudence > United States; Infant > Congress > United States
• Online Access: Click Here to View Status and Holdings.
• Physical Description: xxiii, 408 pages illustrations 24 cm
• Bibliography: Includes bibliographic references and index
• ISBN: 9780309225496; 0309225493

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