Safe and Effective Medicines for Children : Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
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 medicinePharmacology
Ksh 11,700.00
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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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