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Submission Deadlines and Process | Rare Disease Endpoint Advancement Pilot Program

The quarterly submission deadlines for proposals to the Rare Disease Endpoint Advancement Pilot Program are March 31, June 30, September 30, and December 31.  Sponsors may submit a proposal to the RDEA program on a rolling basis through June 30, 2027. FDA will review all RDEA proposals received in the preceding three-month submission cycle after each submission deadline.

RDEA Pilot Program
Quarterly proposal submission deadlines
March 31 June 30 Sept. 30 Dec. 31

FDA will select a maximum of one RDEA proposal and one alternate proposal submitted during the fourth quarter of fiscal year 2023 (July 1, 2023, through September 30, 2023).  FDA will select one primary RDEA proposal and one alternate proposal per submission quarter in FY 2024 through third quarter of FY 2027, with a maximum of three RDEA proposals per year.

Sponsors will be notified whether they will proceed to disclosure discussions or their RDEA proposal has been denied approximately 60 days after the submission deadline. For each RDEA proposal admitted to the Program, FDA will conduct an initial RDEA meeting and, if requested, up to three follow-up meetings.

How to Submit an RDEA Proposal

If you have an active Pre-IND or IND, submit your RDEA Pilot Program proposal to that application.  If you do not have an active Pre-IND or IND, request a pre-assigned number for your RDEA Pilot Program proposal and then submit the proposal to your newly created Pre-IND application. Instructions for electronic submission are available at Electronic Regulatory Submission and Review.

Requesting a pre-assigned application number:

  • Additional information for requesting a pre-assigned number for CBER is available in CBER SoPP 8117.
  • Additional information for requesting a pre-assigned number for CDER is available at Requesting a Pre-Assigned Application number.
  • If requesting a CDER pre-assigned application number for an RDEA proposal of a rare disease natural history study without an associated investigational product, please reach out to RDEA.Meetings@fda.hhs.gov in advance to notify the RDEA Team of your intention to request a CDER pre-assigned application number.

Additional Information:

  • All RDEA Pilot Program submissions should have “RDEA Pilot Program Submission” in the submission header.
  • In addition, please send an email to RDEA.Meetings@fda.hhs.gov providing notification that your RDEA Pilot Program proposal has been submitted to the relevant application.
 
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