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Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

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.

Grant (non-repayable) Open now

Funder
Food and Drug Administration
Funder profile and all of its programs
Amount
Up to $900,000 per award (published on Grants.gov).
Where
United States (federal)
Eligibility
Eligible applicant types are set out on the official page. No cost sharing is required.
Sectors
Agriculture and agri-food, Health and life sciences, Research and science
Deadline
Closes 16 May 2028
Source
Grants.gov XML extract (RFA-FD-25-020)
Last checked
2 November 2026
Funder contacts
Public organizational contacts on file Unlock full profile / Sign up

Official page ↗

From official open data: listed in the official Grants.gov extract on 2026-11-02. The summary is from the official listing; the eligibility line is our plain-language reading of its eligibility codes. Confirm details on the official page.

Related grant lists

Agriculture and agri-food Health and life sciences Research and science Nonprofits and charities United States United States (national) Federal agency $500,000 to $1 million May 2028

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