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

ID: FOR-FD-25-020 • Type: Forecasted
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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.

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Overview

Agency
Food and Drug Administration (FDA) [HHS]
Category of Funding
Agriculture
Consumer Protection
Food and Nutrition
Funding Instruments
Grant
Grant Program (CFDA)
93.103 - Food and Drug Administration Research
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
Grants.gov
On 7/11/25 Food and Drug Administration forecasted grant opportunity FOR-FD-25-020 for Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required). The grant will be issued under grant program 93.103 Food and Drug Administration Research.

Timing

Posted Date
July 11, 2025, 12:00 a.m. EDT
Last Updated
July 11, 2025, 8:24 a.m. EDT
Version
1

Eligibility

Eligible Applicants
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Info
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.

Contacts

Contact
Kimberly Pendleton
Contact Email
kimberly.pendleton@fda.hhs.gov   Profile
Email Description
Business e-mail address

Documents

Posted documents for FOR-FD-25-020

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