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# Pediatric Drug Exclusivity Draft Guidance
- URL: https://www.fdaweb.com/pediatric-drug-exclusivity-draft-guidance/
- Published: 2023-05-18T12:00:00.000Z
- Updated: 2026-09-14T18:32:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154486

*Federal Register* notice: FDA makes available a draft guidance entitled “Pediatric Drug Development: Regulatory Considerations — Complying with the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity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.” The document describes the process for qualifying for pediatric exclusivity and the protections that pediatric exclusivity offers. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-05-18/pdf/2023-10610.pdf?ref=fdaweb.com).