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# Draft Guide on Pediatric Drug Development
- URL: https://www.fdaweb.com/draft-guide-on-pediatric-drug-development/
- Published: 2023-05-18T12:00:00.000Z
- Updated: 2026-09-14T18:32:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154485

Federal Register notice: FDA is making available a draft guidance entitled “Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations.” The document 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 or the Best Pharmaceuticals for Children Act. This draft guidance is intended to assist industry in obtaining the data and information necessary to support To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-05-18/pdf/2023-10611.pdf?ref=fdaweb.com).