GrantSet

Grant opportunity · RFA-FD-25-017

Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)

Applications close558 days leftFeb 8, 2028
AgencyFood and Drug Administration
CategoryDiscretionary
Assistance listing93.103
OpensJul 11, 2025
ClosesFeb 8, 2028
Award floor$0
Award ceiling$600,000
Expected awardsNot stated

Who can apply (as listed)

  • Others (see the opportunity text)
From the listing

The purpose of this notice of funding opportunity (NOFO) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development. 

Excerpt as published. The full synopsis, required forms, and any amendments are on the official listing.

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