Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01)
Food and Drug Administration
Description
This grant opportunity supports clinical trials for rare neurodegenerative diseases that currently lack adequate treatment options. The trials should focus on assessing the safety and effectiveness of medical products to either introduce a new usage or modify existing labeling. The FDA encourages using innovative trial designs to speed up drug development.
This Notice of Funding Opportunity (NOFO) supports clinical trials in all phases of product development for rare neurodegenerative diseases with unmet needs. The trials should evaluate the safety and/or efficacy of medical products in support of a new indication or a change in labeling. The FDA …
Source
Grant ID
RFA-FD-25-001
Agency
Food and Drug Administration
Subcategory/Subagency
Food and Drug Administration
Key Dates
Opportunity Released
August 14, 2024
Eligibility
The following categories of applicants are invited to apply:
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- U.S. Federal Government
- U.S. Territory or Possession
- 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)
- Non-domestic (non-U.S.) components of U.S. Organizations
- Public/State-Controlled Institutions of Higher Education
- Private 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)
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
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