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

Food and Drug Administration

Description

This grant opportunity aims to fund clinical trials focusing on the effectiveness and safety of products for new uses or labeling changes to meet unmet needs in rare diseases. The goal is to increase the number of approved treatments for rare diseases by supporting collaborative, efficient, and innovative trials, ultimately having a broad and positive impact on drug development for these conditions.

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 innovat…

Source

Grant ID

FOR-FD-25-020

Funding Source

Food and Drug Administration

Eligibility

The following categories of applicants are invited to apply:

  • Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Eligibility 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 Governme…
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