Health and Human Services Department, Food and Drug Administration
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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2026-N-4492] ( printed page 25897) AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for information; establishment of a public docket. SUMMARY: 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. DATES: Submit either electronic or written comments, data, or information by June 11, 2026. ADDRESSES: You may submit comments, data, and information as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 11, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. Electronic Submissions Submit electronic comments in the following way: Federal eRul…
Other Federal Register documents from the same docket.
Citation: 91 FR 25897
