The FDA is offering this grant to fund crucial clinical trials focused on products addressing unmet needs in rare diseases or conditions. This opportunity aims to support studies evaluating the efficacy and safety of new indications or labeling changes for orphan products. By funding collaborative, efficient, and innovative clinical trials, the FDA seeks to significantly increase the number of approved treatments for rare diseases. This initiative is designed to exert a broad and positive impact on the overall rare disease drug development landscape, ultimately improving patient outcomes and expanding therapeutic options for these underserved conditions.
Opportunity ID: 359987
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | FOR-FD-25-020 |
| Funding Opportunity Title: | Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | – |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | – |
| Archive Date: | – |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | – |
| Description: | – |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
–
Email:Kimberly.Pendleton@fda.hhs.gov |
Version History
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