Event
ADEPT-10: Addressing Challenges in Neonatal Product Development Leveraging Rare Disease Frameworks
Friday, February 6, 2026
8:30 a.m.-4:00 p.m.
FDA White Oak Campus, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD, 20993
Elena Russ
301 405 4837
esten@umd.edu
https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/advancing-development-pediatric-therapeutics-adept-10-addressing-challenges-neonatal-product
ADEPT-10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks
Dates: February 5-6, 2026
About the Event:
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.
For more details and registration information, visit: FDA ADEPT 10 workshop website
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.
Funding Statement
This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award to the Center of Excellence in Regulatory Science & Innovation, U01FD005946, funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
