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Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

The purpose of this opportunity 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) Opening soon

Funder
Food and Drug Administration
Funder profile and all of its programs
Amount
Award amounts are not published in the listing; see the official page.
Where
United States (federal)
Eligibility
Eligible applicant types are set out on the official page. No cost sharing is required. Forecast: the funder has announced this opportunity but not yet opened it; dates are estimates.
Sectors
Agriculture and agri-food, Health and life sciences, Research and science
Deadline
Varies: check the official page for current dates
Source
Grants.gov XML extract (FOR-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

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