The Food and Drug Administration (FDA) is offering Drug Development Tools Research Grants (U01) through a Cooperative Agreement funding instrument. This opportunity falls under the category of Food and Nutrition and is currently open for applications. The grants aim to support the development of drug development tools that have an accepted or reviewable Letter of Intent (LOI) within the FDA's Drug Development Tool Qualification Program. These tools are intended to fill unmet needs in drug development and will be made publicly available once qualified.
The grants do not require cost sharing or matching requirements. The estimated total program funding is $6 million, with an expected number of 6 awards to be granted. The award ceiling and floor are both set at $500,000. The closing date for applications is May 13, 2025, and the archive date is June 12, 2025.
Eligible applicants include developers of drug development tools who have an accepted or reviewable LOI within the FDA's Drug Development Tool Qualification Program and are working towards their qualification plan or full qualification package. Previous recipients of DDT research grant support from FDA-CDER/CBER are also eligible to apply if they have successfully progressed to the next submission milestone and are requesting additional funding for new DDT project needs addressing different aspects of the project.
For more information and to apply, please visit the following link: RFA-FD-24-030 Funding Opportunity Announcement. If you have any questions, you can contact Terrin Brown, the grantor, at terrin.brown@fda.hhs.gov.