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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)

Food and Drug Administration

Funding Amount

Up to $900,000

Deadline

May 16, 2028

589 days left

Grant Type

Federal

Can we apply?

Check your organization against each line. Taken from the listing; confirm with the funder's guidelines.

Eligible organizations

  • Higher Education InstitutionsPublic/State Controlled Institutions of Higher Education.
  • Private Institutions of Higher Education.
  • Nonprofits Other Than Institutions of Higher Education.
  • Small BusinessesFor-Profit Organizations (Other than Small Businesses)Local Governments.
  • County Governments.
  • Special District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)Federal Governments U.S.
  • Independent School Districts.
  • Native American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based Organizations.

Required status

  • 501(c)(3) tax-exempt status

Other requirements

  • Eligible Organizations.
  • State Governments.
  • City or Township Governments.
  • Territory or PossessionOther.

Overview

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.

Details

  • Agency: Food and Drug Administration
  • Department: Department of Health and Human Services
  • Opportunity #: RFA-FD-25-020
  • Instrument: grant

Eligibility

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 OrganizationsNo

Focus Areas & Funding Uses

Fields of Work

  • Science research

Categories

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