Books > Medicine > Clinical & internal medicine > Paediatric medicine
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Safe and Effective Medicines for Children - Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act (Paperback)
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Safe and Effective Medicines for Children - Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act (Paperback)
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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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