Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) is offered by Food and Drug Administration. Max award: Not specified. This is a forecast; the deadline is not set yet.
| Opportunity number | FOR-FD-25-020 |
|---|---|
| Agency | Food and Drug Administration |
| Status | Forecasted |
| Posted | Jul 11, 2025 |
| Closes | Not set |
| Award ceiling | Not specified |
| Award floor | Not specified |
| Total program funding | Not specified |
| Expected awards | Not specified |
| Who can apply | Others (see text field entitled "Additional Information on Eligibility" for clarification) |
| Category | Agriculture, Consumer Protection, Food and Nutrition |
Summary (excerpt)
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 deve…
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