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

FDA Grant for Clinical Trials of Orphan Products Addressing Rare Diseases

This opportunity from the Food and Drug Administration (FDA) supports clinical trials for orphan products addressing rare diseases. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA), Office of Orphan Products Development (OOPD) - Products/Services Requested: - Clinical trial services for drugs, biologics, medical devices, or medical foods targeting rare diseases - All phases of clinical trials (phases 1, 2, and 3) - Innovative research methods such as data simulations and modeling are encouraged - Eligible Applicants: - Higher education institutions, nonprofits, for-profit organizations, government agencies, and foreign organizations - Funding Details: - Maximum annual award: $900,000 - Minimum annual award: $650,000 - Up to four years of support - Unique Requirements: - Applications must propose clinical trials for orphan products - Focus on increasing approved treatments for rare diseases - No specific OEMs or vendors are named, as the grant supports a wide range of clinical research initiatives

Description

This Notice of Funding Opportunity (NOFO) from the Food and Drug Administration aims to fund clinical trials evaluating the efficacy and/or safety of products for new indications or labeling changes to address unmet needs in rare diseases. The funding supports clinical trials across all phases of product development for orphan products. The goal is to increase the number of approved treatments for rare diseases through collaborative, efficient, and innovative clinical trials. Eligible applicants include a wide range of organizations such as higher education institutions, nonprofits, for-profit organizations, government entities, and foreign organizations. The award provides up to four years of support with a maximum annual budget of $900,000 for innovative trial approaches.

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