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

Open

Food and Drug Administration

Deadline: federal

Updated: Oct 30, 2025

Summary

The grant aims to fund clinical trials that evaluate the efficacy and safety of products for new indications or labeling changes to address unmet needs in rare diseases, with the goal of increasing the number of approved treatments. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local and state governments, and foreign entities. Application details are not specified, but interested parties can contact Kimberly Pendleton at the provided email for more information.

Full Description

Description

The purpose of this opportunity is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.

Eligibility

Eligible applicants

Miscellaneous

  • Other

Additional information

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Local Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Federal Governments  U.S. Territory or Possession Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) Foreign Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Grantor contact information

Description

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Email

Business e-mail address

Kimberly.Pendleton@fda.hhs.gov

Apply on official siteUpdated Oct 30, 2025

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