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Posted: 09/20/2023
 Call for Submissions!
FDA’s Rare Disease Endpoint Advancement (RDEA) Pilot Meeting Program is accepting RDEA proposals for this quarter until September 30, 2023. The RDEA Pilot Meeting Program is designed to support novel endpoint efficacy development for drugs that treat rare diseases by providing a mechanism for sponsors to collaborate with FDA throughout the efficacy endpoint development process. The RDEA Pilot Meeting Program provides an opportunity for sponsors whose proposals are admitted to the program to interact with FDA experts at up to four meetings designed specifically to discuss their proposed novel endpoint.
RDEA proposals may be submitted on a rolling basis and must be received by the last calendar day of each quarter.
Quarterly proposal submission deadlines:
- March 31
- June 30
- September 30
- December 31
For more information about the program and how to submit an RDEA proposal, please see the recently updated RDEA Pilot Program webpage and the RDEA Pilot Program Frequently Asked Questions webpage.
Request for Comments
Draft Guidance on Manufacturing Changes
New draft guidance on manufacturing changes and comparability for human cellular and #GeneTherapy products. Listen to this recorded webinar for a high-level overview and submit comments to the docket by November 13, 2023: https://bit.ly/3PfJQSX
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