Comments Extended and Workshop Planned for Drug Repurposing

FDA is extending the comment period by 30 days for its request for information on drug repurposing for unmet medical needs. Under the initiative, the agency is seeking to identify potential new uses — such as a new indication or a new population — for FDA-approved drugs and to help accelerate the availability of treatments by using existing knowledge about the drugs, including a drug's safety profile.

The comment period is extended through 7/11. Comments can be submitted through the federal eRulemaking Portal to docket FDA-2026-N-4492. 

Additionally, FDA is announcing an 8/5 hybrid public workshop on drug repurposing, convened by the Reagan-Udall Foundation for FDA. The meeting will include an overview of comments submitted to the public docket, as well as discussion of potential approaches for prioritizing and selecting promising candidates for drug repurposing.