The Food and Drug Administration (FDA) is offering a federal grant opportunity titled "Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)." This grant aims to fund clinical trials that evaluate the efficacy and safety of products intended to address unmet needs in rare diseases or conditions, with the goal of increasing the number of approved treatments in this area. The initiative is crucial for enhancing drug development for rare diseases, thereby potentially improving patient outcomes. Interested applicants, including higher education institutions, nonprofits, for-profit organizations, and various levels of government, can reach out to Kimberly Pendleton at Kimberly.Pendleton@fda.hhs.gov or call 240-402-7610 for more information. The opportunity is currently posted for the fiscal year 2025, with no cost-sharing or matching requirements.