Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

The Food and Drug Administration, under the Department of Health and Human Services, is seeking to fund clinical trials for orphan products that evaluate the safety and efficacy of treatments for rare diseases or conditions. The primary objective is to support new indications or changes in labeling to address critical unmet medical needs, thereby increasing the availability of approved treatments and improving the overall landscape of rare disease drug development. This opportunity is listed as a forecast with a posted date of July 11, 2025, and falls under NAICS code 541715. Interested parties can find further details through the grants.gov portal, and inquiries may be directed to the point of contact, Kimberly Pendleton.