Federal Register #FDA-2026-N-4492

FDA Request for Information on Drug Repurposing for Unmet Medical Needs

The Food and Drug Administration (FDA) is seeking public input to support its initiative on drug repurposing for unmet medical needs. - Government Buyer: - Department of Health and Human Services, Food and Drug Administration (FDA) - Scope of Request: - Soliciting information and ideas, not procurement of goods or services - Focus on repurposing FDA-approved drugs for new uses where there is no commercial interest - Requested Input: - Priority disease areas (e.g., metabolic diseases, neurodegenerative conditions, women's and men's health, substance use disorders, rare diseases) - Potential drug candidates for repurposing - Innovative approaches to identify repurposing candidates - Barriers to drug repurposing, including regulatory and commercial challenges - Scientific evidence and real-world data to support suggestions - No OEMs, vendors, products, or part numbers are specified - Notable Requirements: - Emphasis on scientific and real-world evidence - Input from patient, clinical, public health, and research communities - Suggestions for overcoming regulatory and commercial barriers

Description

The Food and Drug Administration (FDA) is opening a public docket to solicit input and comments on its efforts regarding drug repurposing to address unmet medical needs. The FDA is requesting information on potential priority disease areas and candidates for drug repurposing, focusing on FDA-approved drugs with no commercial interest in adding new uses through supplemental applications. The information gathered will help the FDA refine its efforts in evaluating candidates for drug repurposing. The FDA seeks input on priority disease areas, candidates for repurposing, approaches to identifying candidates, and barriers to repurposing drugs.

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