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# New Orphan Product Grant Funding Opportunity
- URL: https://www.fdaweb.com/new-orphan-product-grant-funding-opportunity/
- Published: 2025-07-16T12:00:00.000Z
- Updated: 2026-09-14T15:16:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159514

FDA says it will accept applications until 2/10/2026 for the Office of Orphan Products Development’s Natural History Studies Grant Program. A grant [notice](https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-25-017.html?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the funding opportunity is intended to support prospective or retrospective, efficient, and innovative natural history studies with a focus on collaborative and standardized approaches to ensure data quality and interpretability. 

FDA says it is interested in supporting natural history studies that address unmet needs in rare diseases, particularly in these areas of interest:

- ability to exert a significant impact in the field of rare diseases for future clinical trials;
- inclusion of high-quality interpretable data using well-defined protocols with a rigorous and standardized approach to data collection and analysis, use of common data elements, plans for minimization of bias, data sharing across sites, data dissemination, and collaborative use of data; and
- use of existing infrastructure, resources, and collaboration among stakeholders in industry, academia, and patient organizations.