Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
HHS-FDA Forecasted FOR-FD-25-020Description
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.
Eligibility
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.
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.
Actions
Funding Details
- Award Floor
- Not specified
- Award Ceiling
- Not specified
- Total Estimated Funding
- Not specified
- Expected Awards
- Not specified
Key Dates
- Posted
- July 11, 2025
- Closes
- N/A
- Archive Date
- N/A
Agency Information
- Agency Name
- Food and Drug Administration
- Agency Code
- HHS-FDA
- Funding Instrument
- Other