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 · Food and Drug Administration Research (93.103)
Publicada 11 jul 2025 · Quedan aproximadamente 20 meses
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Resumen aún no disponible en español; se muestra en inglés.
The US Food and Drug Administration funds clinical trials of treatments for rare diseases to support new drug approvals or label changes, with grants up to 900,000 US dollars. Eligible applicants include universities, nonprofits, companies, and governments worldwide, with applications due by 16 May 2028.
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Resumen
Texto original del donante (inglés)
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.
Extracto de la página del donante. El texto completo, los anexos y los formularios están en la convocatoria original.
Regiones elegibles
- Todo el mundo
Quién puede presentar una solicitud
- Institución académica o de investigación
- ONG / sociedad civil
- Empresa privada
- Organismo gubernamental
- Organización comunitaria
Elegibilidad y condiciones
Mostrar el texto de elegibilidad de la fuente · Texto original del donante (inglés)
Applicant types: Others (see text field entitled "Additional Information on Eligibility" for clarification)
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.