Applied Regulatory Science Research to Evaluate Cardiotoxicity of Oncology Therapeutics (U01) Clinical Trial Optional
ID: 360123Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $500K

Eligible Applicants

Others

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/360123

Additional Information

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-25-015.html
Timeline
    Description

    The Food and Drug Administration (FDA) is offering a funding opportunity for applied regulatory science research aimed at evaluating the cardiotoxicity of oncology therapeutics through the U01 Research Project Cooperative Agreements. This initiative seeks to enhance the detection, monitoring, and management of cardiovascular toxicities associated with cancer treatments, focusing on developing standardized definitions, improving monitoring plans, and creating predictive models that consider patient risk factors. With a total funding availability of up to $1.5 million for Fiscal Year 2025, the FDA anticipates awarding 1-3 grants over a maximum three-year project period, with applications due by August 8, 2025. Interested applicants can reach out to Patrick Johnson at patrick.johnson@fda.hhs.gov for further information and are encouraged to review the detailed announcement at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-25-015.html.

    Point(s) of Contact
    patrick.johnson@fda.hhs.gov
    Files
    Title
    Posted
    RFA-FD-25-015.html
    The Department of Health and Human Services is offering a Funding Opportunity Announcement (FOA) supporting applied regulatory science research to evaluate cardiotoxicity related to oncology therapeutics through the U01 Research Project Cooperative Agreements. The initiative aims to improve the detection, monitoring, and management of cardiovascular toxicities caused by cancer treatments, which are increasingly common due to newer therapies. Key focus areas include developing standardized definitions of cardiotoxicity, improving monitoring plans, and creating predictive models that account for patient risk factors. The total funding available is up to $1.5 million for Fiscal Year 2025, supporting 1-3 awards over a maximum three-year project period. Applications are due on August 8, 2025, with no late submissions accepted. Eligible organizations include public and private educational institutions, nonprofits, and government entities. The funding aims to foster collaborative networks to analyze data and enhance generalizability across studies. Investigators are urged to prioritize practical solutions to regulatory science challenges, rather than developing therapeutic products. The FOA underscores the FDA's commitment to advancing safe cancer therapies while actively mitigating associated risks to patients.
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