Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) is offered by Food and Drug Administration. Max award: $900,000. Applications close on May 16, 2028.
| Opportunity number | RFA-FD-25-020 |
|---|---|
| Agency | Food and Drug Administration |
| Status | Posted |
| Posted | Jul 11, 2025 |
| Closes | May 16, 2028 |
| Award ceiling | $900,000 |
| Award floor | Not specified |
| Total program funding | Not specified |
| Expected awards | Not specified |
| Who can apply | Others (see text field entitled "Additional Information on Eligibility" for clarification) |
| Category | Agriculture, Consumer Protection, Food and Nutrition |
Summary (excerpt)
The purpose of this Notice of Funding Opportunity (NOFO) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact …
View the official listing and apply on Grants.gov
Before you apply
- Register your organization in SAM.gov and get a UEI — it can take weeks
- Create a Grants.gov account and check eligibility in the full notice (NOFO)
- Start early; the system gets busy near deadlines
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