Drug Repurposing for Unmet Medical Needs; Request for Information

The Food and Drug Administration (FDA, the Agency, or we) is opening a public docket to solicit input and comments on FDA's efforts with respect to drug repurposing to address unmet medical needs. FDA is requesting information on potential priority disease areas and potential candidates for drug repurposing, with a focus on FDA-approved drugs for which there appears to be no commercial interest in adding a new use through a supplement to a new drug application (supplemental application). Information provided through this public docket will help the Agency refine our efforts toward considering and evaluating candidates for drug repurposing.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.