The FDA is extending the comment period by 30 days for the Request for Information on Drug Repurposing for Unmet Medical Needs.
On May 12, 2026, the FDA issued a Request for Information to solicit input and comments on FDA's efforts with respect to drug repurposing to address unmet medical needs.
Identifying potential new uses—such as a new indication or a new population—for FDA-approved drugs can help accelerate the availability of treatments by using existing knowledge about the drugs, including a drug's safety profile.
The original comment period was scheduled to close on June 11, 2026. The agency is extending the comment period by 30 days, until July 11, 2026, to allow interested parties additional time to submit comments.
Comments can be submitted via the Federal eRulemaking Portal to docket FDA-2026-N-4492.
Additionally, FDA will hold a hybrid public workshop on drug repurposing, convened by the Reagan-Udall Foundation for the FDA, on August 5. 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.
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