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Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development-Leveraging Rare Disease Frameworks; Public Meeting

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

Document type
Notice
Agency
Health and Human Services Department
Published
September 22, 2025
Document number
2025-18273
ABSTRACT

The Food and Drug Administration (FDA or we) is announcing the following public workshop entitled "Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development--Leveraging Rare Disease Frameworks." The aim of the public workshop is to discuss common challenges in neonatal and rare disease product development and identify opportunities to leverage rare disease product development frameworks in the neonatal product development space.

Abstract as published in the Federal Register.

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