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FDA — Food and Drug Administration

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases

Funds clinical trials testing whether a product works and is safe for a rare disease, aimed at a new indication or a labeling change.

Most rare diseases have no approved treatment, and the ones that do often got there through a small, hard-won trial rather than a large one. This notice funds that trial.

The money supports clinical trials evaluating a product's efficacy and safety in support of a new indication or a labeling change for a rare disease or condition. FDA names the goal directly: more approved treatments for rare di

Clinical trials evaluating the efficacy and/or safety of a product for a rare disease or condition, in support of a new indication or a labeling change, favouring collaborative, efficient or innovative trial designs. A clinical trial is required under this activity code.

CycleiHow often this grant runs — e.g. annually, on a rolling basis, or a one-off call.One-off
Next deadlineiThe next date applications are due. Rolling means you can apply any time.16 May 2028
Decision timeiTypical time from the deadline to the funder's decision.
Project durationiHow long the funded work is expected to run.
Award typeiThe form of funding — grant, equity, loan, tax credit, etc.Grant
Match fundingiThe share of project costs you must cover yourself. 0% = fully funded.
Funding pooliThe total budget available across all awards in this round.

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Last verified: 25 Aug 2026Funder reference: RFA-FD-25-020Source: www.grants.gov