Drug Development Tools Research Grants (U01) Clinical Trials Optional
Grants support research to advance drug development tools already in qualification programs, making them publicly available to address unmet needs.
This grant is no longer accepting proposals
Food and Drug Administration has archived this opportunity.
Funder: Food and Drug Administration
Due Dates: May 13, 2025 (Application Due)
Funding Amounts: Up to $500,000 total costs per award (max 2 years; $250,000/year); typically 1-year projects; ~6 awards/year
Summary: Supports research to advance drug development tools in FDA qualification programs, making them publicly available to address unmet needs in drug development.
Key Information: Applicants must have an accepted or reviewable Letter of Intent (LOI) in a CDER/CBER Drug Development Tool Qualification Program at the time of application.
Description
This opportunity funds research to further develop drug development tools (DDTs) that are already in the FDA’s qualification pipeline—specifically, those with an accepted or reviewable Letter of Intent (LOI) in the Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) Drug Development Tool Qualification Programs. The goal is to support the advancement of DDTs (such as biomarkers, clinical outcome assessments, animal models, or digital health technologies) so that, once qualified, they can be made publicly available to fill unmet needs in drug development and regulatory science.
Projects should focus on advancing the tool toward the next qualification milestone (e.g., Qualification Plan or Full Qualification Package), rather than describing the entire development effort. The FDA encourages applicants to target specific gaps or recommendations identified by the agency.
