Drug Development Tools Research Grants (U01) Clinical Trials Optional
Grant Opportunity Analysis
The U.S. Food and Drug Administration (FDA) is offering funding through the Drug Development Tools Research Grants (U01) Clinical Trials Optional, aimed at supporting research focused on Drug Development Tools (DDTs) that have an accepted or reviewable Letter of Intent within the qualification programs at the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). The grants are intended to address significant gaps in drug development by facilitating the qualification of methods, materials, or measures designed to expedite the process, ultimately enhancing public health outcomes. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, and government entities, with a funding ceiling of $500,000 per project over one or two years. Interested parties must submit their applications by May 13, 2024, or May 13, 2025, and can contact Terrin Brown at terrin.brown@fda.hhs.gov for further information.
Eligible Applicants
These grants will be used to provide funding to developers of drug development tools that have an accepted or a reviewable Letter of Intent (LOI) within a CDER/CBER's Drug Development Tool Qualification Program and are working towards their qualification plan (QP) or full qualification package (FQP).If you received DDT research grant support from FDA-CDER/CBER in previous years, you are eligible to apply provided that you have successfully progressed to the next submission milestone (e.g., Accepted LOI to Accepted QP) and are requesting additional funding for new DDT project needs addressing different aspects of the project.