The U.S. Food and Drug Administration is preparing to launch their Rare Disease Endpoint Advancement (RDEA) Pilot Program as part of their commitment under the Prescription Drug User Fee Act (PDUFA) IV. The goals of the RDEA Pilot Program are to:
- Seek to advance rare disease drug development programs
- Promote innovation and evolving science
- Develop FDA staff capacity to evaluate the efficacy of rare disease therapies.
More detailed objectives can be found on the RDEA Pilot Program page along with information on RDEA program proposal requests, proposal eligibility requirements, and proposal selection.
Rare Disease Endpoint Advancement Pilot Program
Additional Information
