Opportunity

Simpler Grants.gov #FOR-FD-25-020

FDA Grant for Clinical Trials Addressing Unmet Needs in Rare Diseases

Buyer

Food and Drug Administration

Posted

July 11, 2025

Identifier

FOR-FD-25-020

NAICS

541715

The Food and Drug Administration (FDA) is offering a grant opportunity to support clinical trials targeting unmet needs in rare diseases. - Government Buyer: - Food and Drug Administration (FDA) - Products/Services Requested: - Clinical trial research services for rare diseases - Focus on evaluating efficacy and/or safety of products to support new indications or labeling changes - Eligible Applicants: - Higher education institutions, nonprofits, for-profit organizations, government entities, and tribal organizations - Notable Requirements: - No specific OEMs or vendors are named, as this is a research grant - No cost sharing or matching required - Funding is under assistance listing 93.103 (FOR-FD-25-020) - Objective: - Increase the number of approved treatments for rare diseases through collaborative, efficient, and innovative clinical trials

Description

This opportunity funds clinical trials of products evaluating efficacy and/or safety to support new indications or labeling changes addressing unmet needs in rare diseases or conditions. The goal is to increase the number of approved treatments for rare diseases through collaborative, efficient, and innovative clinical trials. The funding is provided by the Food and Drug Administration under assistance listing 93.103. Eligible applicants include a wide range of organizations such as higher education institutions, nonprofits, for-profit organizations, government entities, and tribal organizations.

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