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

February 5 and 6 2026

Summary

The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (MCERSI), is announcing the following public workshop titled "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.  

Topics for Discussion

The specific topics for discussion at this workshop include, but are not limited to, the following: 

• Identifying common challenges in neonatal and rare disease product development.
• Discussing ethical considerations relevant to neonatal and rare disease product development.
• Identifying opportunities to leverage rare disease tools and strategies for neonatal conditions. 
• Discussing the regulatory landscape of rare disease programs/resources and their application to neonatal conditions.