Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Open to nearly any organization — universities, nonprofits (with or without 501(c)(3)), for-profits and small businesses, state/local/tribal governments, and foreign organizations. This FDA R01 fun…
- Deadline
- May 16, 2028
- Posted
- Jul 11, 2025
- Award amount
- Up to $900,000
Don’t miss this deadline
We’ll email you before May 16, 2028 so you have time to apply.
In plain English
Open to nearly any organization — universities, nonprofits (with or without 501(c)(3)), for-profits and small businesses, state/local/tribal governments, and foreign organizations. This FDA R01 funds clinical trials of orphan products evaluating safety and efficacy to address unmet needs in rare diseases. Awards up to about $900,000; clinical trials are required.
AI-generated summary to help you decide quickly — verify the official eligibility rules before applying.
Who can apply
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 GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)Federal Governments U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations)Foreign OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
About this grant
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.
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Source: public records via Grants.gov. UseGrants is an independent aggregator, not affiliated with any funding agency. Always confirm details on the official listing before applying.