22 Sep 2025

🏥Public Workshop on Pediatric Therapeutics and Neonatal Product Development

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

Summary

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.

Agencies

  • Health and Human Services Department
  • Food and Drug Administration

Business Impact ?

$$ - Med

The public workshop discusses neonatal product development, offering businesses opportunities to identify challenges and explore regulatory frameworks that can impact industry practices. It promotes dialogue among stakeholders, potentially shaping future regulations and support for pediatric therapeutics.

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