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.In 2004, CDER added to its policy manual a standardized template for clinical reviews, although some reviewers had been ... In addition, CDER has created a 65-page desk reference guide that provides staff with an accessible resource ofanbsp;...
|Title||:||Safe and Effective Medicines for Children|
|Author||:||Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), Board on Health Sciences Policy, Institute of Medicine|
|Publisher||:||National Academies Press - 2012-09-27|