Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required

The U.S. Food and Drug Administration (FDA), under the Department of Health and Human Services, has announced a forecasted grant opportunity aimed at addressing critical gaps in the treatment of rare neurodegenerative diseases. Titled "Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required," this initiative supports clinical trials evaluating the efficacy and/or safety of medical products with the goal of obtaining new indications or label changes for both children and adults affected by these rare conditions. This funding opportunity seeks to increase the number of FDA-approved treatments for rare neurodegenerative diseases by supporting collaborative, efficient, and innovative clinical trials. The program emphasizes the importance of trials that can directly support regulatory decision-making processes and significantly improve the availability of safe and effective therapeutic options for underserved patient populations. Funding under this initiative will be structured as a grant with expected awards ranging from $650,000 to $900,000. Specific total program funding and the expected number of awards have not yet been disclosed. Cost sharing or matching is not required for participation. The assistance is categorized under the FDA’s research activities, specifically CFDA 93.103. Eligibility for this opportunity is broadly inclusive. It is open to a wide range of entities including state, county, and city governments; public and private institutions of higher education; independent school districts; special district governments; for-profit organizations including small businesses; public housing authorities; Native American tribal governments and organizations; and nonprofits with or without 501(c)(3) status. There are no geographic restrictions, implying a nationwide reach. The official application due date, estimated posting date, and award start date are not yet specified. The opportunity was last updated and forecasted on August 14, 2024, for fiscal year 2025. Interested applicants are advised to monitor the Grants.gov listing for future updates regarding submission deadlines and requirements. For further information, the primary contact is Terrin Brown, reachable at [email protected] or 240-402-7610.