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

by Board on Health Sciences Policy , Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the P , Institute of Medicine

Book Details

Format Paperback / Softback

ISBN-10 0309225493

ISBN-13 9780309225496

Publisher National Academies Press

Imprint National Academies Press

Country of Manufacture US

Country of Publication GB

Publication Date Oct 13th, 2012

Print length 432 Pages

Weight 724 grams

Dimensions 23.10 x 15.40 x 2.60 cms

Product Classification: Paediatric medicine Pharmacology

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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.

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