2023-10611: Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations." This draft guidance addresses selected clinical, scientific, and ethical issues involved in developing drugs, including biological products, for pediatric use when such drug products are subject to the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act (BPCA). This draft guidance is intended to assist industry in obtaining the data and information necessary to support the approval of drug products in pediatric populations. This draft guidance does not address the clinical development of drug products that are not subject to either PREA or the BPCA.
The agency’s own summary, as published.
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