At a glance
Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) is a federal competitive grant from Food and Drug Administration for the science & technology sector. Eligible applicants: Others (see text field entitled "Additional Information on Eligibility" for clarification). Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Educat. Applications are accepted on a rolling basis. Apply via the official listing at www.grants.gov.
- Amount
- See listing
- Deadline
- Rolling
- Type
- Competitive
- Status
- Forecasted
About this program
The purpose of this opportunity 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.
Who can apply
Others (see text field entitled "Additional Information on Eligibility" for clarification). Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits 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 Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Local Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Federal Governments U.S. Territory or Possession Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) Foreign Organizations Non-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.
How to apply
Apply through Grants.gov using funding opportunity number FOR-FD-25-020. Register your organization (SAM.gov + Grants.gov) before the deadline, then submit the application package listed in the official notice.
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