FDA ADEPT 10: Addressing Challenges in Neonatal Product Development

February 5 – 6, 2026

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DAY 1: Thursday, February 5th, 2026

Welcome and Introductory Remarks

Session 1: Setting the Scene – Neonatal and Rare Disease Drug Development

Session 2: Ethical Considerations in Neonatal and Rare Disease Clinical Trials

DAY 2: Friday, February 6th, 2026

Session 3: Innovative Strategies for Neonatal and Rare Disease Clinical Trials (Part 1)

Session 3: Innovative Strategies for Neonatal and Rare Disease Clinical Trials (Part 2)

Session 4: Regulatory Landscape and Future Directions for Neonatal and Rare Disease Drug Development

Summary and Closing Remarks

About:

This February 5-6, 2026 workshop was presented by The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (MCERSI). The aim of the public workshop was 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:

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.

Course Information

Categories: Biologics, Drugs