Drug Development Tools Research Grants (U01 Clinical Trial Optional)

The drug development tool programs at FDA are created to assist the applicants to successfully complete the qualification process, and to make the qualified tools available openly. Not only the program staff but also subject matter experts from FDA are involved to guide them to create most useful and widely acceptable tools through meetings and other means of interactions with FDA. Contract mechanism is not suitable for these programs as the applications are originated from external organizations such as academia or industries, and the research is carried out by the external organizations, often in collaborations with many interested parties.