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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)

Open

Food and Drug Administration

Deadline: May 16, 2028federal

Updated: Oct 30, 2025

Summary

The purpose of this grant is to fund clinical trials that evaluate the efficacy and safety of products for new indications or labeling changes to address unmet needs in rare diseases, ultimately aiming to increase the number of approved treatments in this area. Eligible applicants include a wide range of organizations such as higher education institutions, nonprofits, for-profit organizations, government entities, and foreign organizations. Application details are not specified in the provided information, but interested parties can contact Kimberly Pendleton at the FDA for further inquiries.

Full Description

Description

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.

Eligibility

Eligible applicants

Miscellaneous

  • Other

Additional information

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.

Grantor contact information

Description

Kimberly Pendleton Chief Grants Management Officer

Email

Email: Kimberly.Pendleton@fda.hhs.gov

Kimberly.Pendleton@fda.hhs.gov

Apply on official siteUpdated Oct 30, 2025

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