Applied Regulatory Science Research to Evaluate Cardiotoxicity of Oncology Therapeutics (U01) Clinical Trial Optional
Closed Posted
- Opportunity number
- RFA-FD-25-015
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Applications due
- Award size
- Up to $500,000
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Categories
-
- Agriculture
- Consumer Protection
- Food and Nutrition
- Eligible applicants
-
- Public or Indian Housing Auth.
- Higher Education Inst. (Private)
- Higher Education Inst. (Public)
- 501(c)(3) Nonprofits
- Tribal Governments (Federally Recognized)
- Small Businesses
- Special District Governments
- Independent School Districts
- County Governments
- City/Township Governments
- State Governments
- Other
- Tribal Organizations (Not Federally Recognized)
- Non-501(c)(3) Nonprofits
- For Profit Organizations
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The Department of Health and Human Services Food and Drug Administration (FDA) is seeking applied regulatory science research proposals focused on improving the detection and monitoring of cardiotoxicity in oncology therapeutics through a cooperative agreement grant. This funding opportunity (ID: 360123-F) is open to a wide range of applicant types, including public and private higher education institutions, nonprofits, tribal governments, small businesses, and governmental entities. The primary objective is to support research that enhances understanding of potential cardiac risks associated with cancer treatments, with a clinical trial component being optional. Eligible applicants will be evaluated based on their research methodology, scientific merit, potential impact on regulatory science, and ability to advance cardiotoxicity monitoring techniques. The grant announcement was posted on July 23, 2025, with proposals due by August 8, 2025, under the Food and Drug Administration Research program (CFDA 93.103).
While specific award amounts are not explicitly stated, the FDA Research program typically funds projects ranging from $20,000 to over $2,000,000, with project periods generally spanning 1-5 years. The performance of research activities will predominantly occur at the recipient's institutional facilities, potentially involving multi-site collaborations or engagement with FDA research centers. Recipients can expect a cooperative agreement format, which implies substantial FDA involvement and collaboration throughout the research process. The grant supports research across various domains including food safety, drug development, and clinical trials, with a specific focus on advancing regulatory science and improving public health outcomes in oncology therapeutics.
Synopsis
The purpose of this Notice of Funding Opportunity (NOFO) is to support applied regulatory science research to improve the detection and monitoring of cardiotoxicity of oncology therapeutics.
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