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"Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01)" is currently closed and not accepting applications.
Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) is sponsored by U.S. Food and Drug Administration (FDA). This funding opportunity aims to support clinical trials evaluating the efficacy and/or safety of products for new indications or changes in labeling to address unmet needs in rare diseases or conditions.
The goal is to increase the number of approved treatments for rare diseases and positively impact rare disease drug development.
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Or search similar grants →According to the current listing, eligibility includes: Nonprofit organizations, public and private institutions, and individuals are eligible to apply. Focuses on clinical trials for rare diseases. Confirm the full requirements in the official notice before applying.
The published deadline was October 21, 2025, which has passed. Check the official notice for any future application windows before investing time in a proposal.
Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) is funded by U.S. Food and Drug Administration (FDA). Verify program details on the funder's official page before applying.
Yes — this listing is flagged as national in scope, so applicants across the U.S. may apply, subject to the sponsor's other eligibility criteria.
Start from the official opportunity page linked in this listing — it carries the sponsor's submission instructions.
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