Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children ACT and the Pediatric Research Equi

by Committee on Pediatric Studies Conducted, Institute of Medicine, Thomas F Boat, et al.

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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...

Format:Paperback

Language:English

ISBN:0309225493

ISBN13:9780309225496

Release Date:October 2012

Publisher:National Academies Press

Length:432 Pages

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Medical Medical Books

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Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children ACT and the Pediatric Research Equi

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