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Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required
Service
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Source |
Final Application Due Date |
Funding Available
|
Match Required
|
|---|---|---|---|---|
| Health Care |
Federal
HHS |
10-22-2024 | N/A | No Match Required |
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Service
-
Source
-
Final Application Due Date
-
Funding Available
-
Match Required
Status
- Opportunity Type Discretionary
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CFDA
93.103 -- Food and Drug Administration Research
Description
The purpose of this funding opportunity announcement (FOA) 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.
Eligibility
- IHE
- Local Government
- Non-Profit
- Other
- State Government
- Tribal Government
Additional Eligibility Information
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.
Key Date(s)
- June 30, 2022: Last Updated Date
- June 30, 2022: Posted Date
- October 22, 2024: Current Closing Date for Applications
- October 22, 2024: Application Due Date
- November 27, 2024: Application Archive Date