Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required
Forecasted Federal grant Posted
- Opportunity number
- FOR-FD-25-001
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Applications expected due
- Not on record
- Award size
- $650,000 to $900,000
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Categories
-
- Consumer Protection
- Food and Nutrition
- Agriculture
- Eligible applicants
-
- Special District Governments
- 501(c)(3) Nonprofits
- Higher Education Inst. (Public)
- Public or Indian Housing Auth.
- Unrestricted
- Independent School Districts
- Tribal Organizations (Not Federally Recognized)
- State Governments
- Small Businesses
- Tribal Governments (Federally Recognized)
- City/Township Governments
- Higher Education Inst. (Private)
- Non-501(c)(3) Nonprofits
- County Governments
- For Profit Organizations
- Points of contact
-
- Terrin Brown terrin.brown@fda.hhs.gov (240) 402-7610
Opportunity details come from Grants.gov. Updated .
About this opportunity
The Food and Drug Administration is forecasting grant funding for clinical trials addressing unmet needs in rare neurodegenerative diseases, with applications due by a date not specified in this forecast. This is a forecast announcement; a Notice of Funding Opportunity with specific deadlines has not yet been released.
Eligible applicants include state and local governments, federally recognized tribal governments, tribal organizations not federally recognized, public and private higher education institutions, public or Indian housing authorities, independent school districts, small businesses, for-profit organizations, 501(c)(3) nonprofits, and non-501(c)(3) nonprofits. The funding instrument is a project grant (R01 mechanism). No cost share or matching requirement is stated.
The program aims to fund clinical trials evaluating efficacy and/or safety of products in support of new indications or labeling changes for rare neurodegenerative diseases in children and adults. The FDA expects support for collaborative, efficient, and innovative trial designs to increase the number of approved treatments and broaden the impact on rare disease drug development.
Award ceilings, award floors, expected number of awards, period of performance, and evaluation criteria are not detailed in this forecast. The opportunity falls under CFDA 93.103 (Food and Drug Administration Research). Recent related awards under this program have ranged from $50 thousand to $6.8 million, though those represent other research categories within FDA's portfolio.
Forecast synopsis
The purpose 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 neurodegenerative diseases for children and adults. Through the support of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare neurodegenerative diseases and exert a broad and positive impact on rare disease drug development.
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