Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
ID: 360008Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $900K

Eligible Applicants

Others

Funding Category

Food and Nutrition

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/360008

Additional Information

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-25-020.html
Timeline
    Description

    The U.S. Food and Drug Administration (FDA) has announced a Notice of Funding Opportunity (NOFO) titled "Reissue of RFA-FD-23-001 - Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)." This initiative aims to fund clinical trials that evaluate the efficacy and safety of orphan products for rare diseases, with the goal of addressing unmet medical needs and increasing the number of approved treatments in this area. The funding opportunity encourages innovative trial designs and collaboration among various stakeholders, emphasizing the importance of patient engagement throughout the research process. Eligible applicants include a wide range of organizations, with funding amounts reaching up to $900,000 per year, and applications are due by May 16, 2028. For further inquiries, interested parties can contact Kimberly Pendleton at Kimberly.Pendleton@fda.hhs.gov.

    Files
    Title
    Posted
    RFA-FD-25-020.html
    The Department of Health and Human Services, through the U.S. Food and Drug Administration (FDA), has released a Notice of Funding Opportunity (NOFO) aimed at supporting clinical trials for orphan products targeting rare diseases. This initiative seeks to address unmet medical needs by evaluating safety and efficacy for new indications in various phases (1, 2, or 3) of drug development. The funding opportunity encourages innovation and collaboration among stakeholders by supporting novel trial designs and patient engagement. Applications are invited from a diverse range of organizations and must adhere to specific submission guidelines, including a detailed budget and compliance with regulatory requirements. Key deadlines include application due dates in October 2025, 2026, and 2027, with funding contingent upon congressional appropriations. Eligible costs can reach up to $900,000 per year with supplementary funding available for innovative designs. Critically, the document outlines rigorous application and review processes, emphasizing the need for sound research rationale, study design, and engagement with patients or caregivers. The FDA aims to expedite drug development through this funding, facilitating a positive impact on the rare disease field and improving treatment options for impacted populations. Overall, this NOFO underscores the FDA's commitment to enhancing the drug approval process for rare diseases via targeted funding mechanisms.
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