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

Forecasted

Food and Drug Administration

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.

Who can apply

  • Others

Contact


Kimberly.Pendleton@fda.hhs.gov

Key dates & funding
  • PostedJul 11, 2025
  • CFDA93.103

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