Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Open. Closes May 16, 2028, 572 days from October 22, 2026, as posted on Grants.gov. Posted by Food and Drug Administration, opportunity number RFA-FD-25-020.
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Notice facts
| Agency | Food and Drug Administration |
|---|---|
| Opportunity number | RFA-FD-25-020 |
| Assistance listing | 93.103 |
| Funding instrument | Grant |
| Category | Agriculture, Consumer Protection, Food and Nutrition |
| Posted | July 11, 2025 |
| Closes | May 16, 2028 |
| Award range | Up to $900,000 |
| Expected number of awards | Not stated |
| Total program funding | Not stated |
| Cost sharing or matching | Not required, per the notice |
| Applicant types listed | Others (see the notice's eligibility text) |
| Additional eligibility information | From the notice: Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationNonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)For-Profit OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)Local GovernmentsState… |
| Where to apply | Check the notice for where and how to submit. |
As posted on Grants.gov, checked October 21, 2026. CedarGrant lists what the notice states; it does not judge whether an organization is eligible. The official notice and its modifications control.
Summary from the notice
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 on rare disease drug development.
Official notice and documents
- Foa_Content_of_RFA-FD-25-020.pdf (Full Announcement)
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