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

Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) is offered by Food and Drug Administration. Max award: $600,000. Applications close on Feb 8, 2028.

Opportunity numberRFA-FD-25-017
AgencyFood and Drug Administration
StatusPosted
PostedJul 11, 2025
ClosesFeb 8, 2028
Award ceiling$600,000
Award floorNot specified
Total program fundingNot specified
Expected awardsNot specified
Who can applyOthers (see text field entitled "Additional Information on Eligibility" for clarification)
CategoryAgriculture, Consumer Protection, Food and Nutrition

Summary (excerpt)

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 specifi…

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