Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required
ID: 356170Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $650K

Eligible Applicants

Unrestricted

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/356170

Additional Information

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-25-001.html
Timeline
    Description

    The Food and Drug Administration (FDA) is offering a funding opportunity for clinical trials aimed at addressing unmet needs in rare neurodegenerative diseases through the Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) initiative. This program seeks to support innovative and collaborative clinical trials that evaluate the efficacy and safety of products intended for new indications or labeling changes, thereby enhancing the development of treatments for these conditions. The funding, which may reach up to $900,000 over a four-year period, is available to a wide range of applicants, including educational institutions, nonprofits, and local governments, with applications due by October 21, 2025. For further details, interested parties can contact Terrin Brown at terrin.brown@fda.hhs.gov or refer to the additional information available at the provided URL.

    Point(s) of Contact
    terrin.brown@fda.hhs.gov
    Files
    Title
    Posted
    RFA-FD-25-001.html
    The FDA's Notice of Funding Opportunity (NOFO) aims to support clinical trials focused on addressing unmet needs in rare neurodegenerative diseases in accordance with the Accelerating Access to Critical Therapies for ALS Act. This initiative promotes the development of orphan products—drugs and devices for rare diseases—by funding R01 Research Project Grants. The NOFO encourages innovative trial designs and collaboration among stakeholders to enhance drug development efficiency. Applications are open until October 21, 2025, and must propose clinical trials evaluating safety and efficacy while meeting specific FDA guidelines. Funding is contingent on federal appropriations, with a potential maximum of $900,000 over four years. Eligible entities include educational institutions, nonprofits, and local governments. The document outlines detailed application requirements and review criteria to ensure compliance with FDA standards. Overall, the NOFO underscores the commitment to expedite the approval of therapies for rare neurodegenerative conditions, leveraging stakeholder engagement and advanced trial designs for better patient outcomes.
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