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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.

FromFood and Drug Administration
Who can applyothers (see eligibility notes)
Eligibility notesEligible 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…
How muchup to $900K per award
DeadlineTue, May 16, 2028 (571 days left)
CategoryAgriculture, Consumer Protection, Food and Nutrition
TypeGrant
Opportunity #RFA-FD-25-020
Assistance listing93.103
PostedFri, Jul 11, 2025

Open the official posting

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.

We may have shortened this. The official posting is the record. We are not affiliated with the agency that published it.