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FDA Issues Pediatric Drug Development Draft Guidance

The new draft guidance assists industry members in obtaining the data and information necessary to support the approval of drug products in pediatric populations.

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The FDA has announced the availability of a draft guidance entitled “Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations.” The draft guidance addresses selected clinical, scientific, and ethical issues involved in developing drugs, including biological products, for pediatric use when such drug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).

Specifically, the draft guidance describes considerations regarding data in pediatric patients with particular discussion regarding formulation development, nonclinical information, clinical pharmacology, and safety information. Additionally, it discusses pediatric extrapolation, timing of pediatric studies, and drug development for the neonatal population. The draft guidance does not address the clinical development of drugs that are not subject to either PREA or the BPCA.

The draft guidance, along with the draft guidance entitled “Pediatric Drug Development: Regulatory Considerations—Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act,” revises and replaces the draft guidance entitled “How to Comply with the Pediatric Research Equity Act.” It also addresses certain additional topics that the FDA has not previously addressed in guidance.

To get a copy of the draft guidance, go to​drugs/​guidance-compliance-regulatory-information/​guidances-drugs,​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics/​biologics-guidances,​regulatory-information/​search-fda-guidance-documents, or

Electronic or written comments on the draft guidance should be submitted by July 17, 2023.

The draft guidance has been issued consistent with FDA’s good guidance practices regulation. It does not establish any rights for any person and is not binding on the FDA or the public.

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