Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required
ID: 341725Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$200K - $650K

Eligible Applicants

Others

Funding Category

Science and Technology and other Research and Development

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/341725

Additional Information

http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-001.html
Timeline
    Description

    The U.S. Food and Drug Administration (FDA) has announced a funding opportunity aimed at supporting clinical trials for orphan products that address unmet needs in rare diseases. This initiative seeks to enhance the approval of treatments for over 7,000 rare diseases affecting approximately 30 million Americans, encouraging innovative trial designs and collaboration among stakeholders such as industry, academia, and patient organizations. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, and various government entities, with funding available up to $650,000 annually for a maximum of four years. Interested parties should submit their applications by September 22, 2024, and can contact Shashi Malhotra at shashi.malhotra@fda.hhs.gov for further information.

    Point(s) of Contact
    shashi.malhotra@fda.hhs.gov
    Files
    Title
    Posted
    RFA-FD-23-001.html
    The U.S. Food and Drug Administration (FDA) has issued a Funding Opportunity Announcement (FOA) aimed at supporting clinical trials for orphan products that address unmet needs in rare diseases. This initiative seeks to enhance the approval of treatments for over 7,000 rare diseases affecting approximately 30 million Americans. The FDA encourages innovative clinical trial designs, which could include seamless and adaptive trials, and emphasizes collaboration among stakeholders such as industry, academia, and patient organizations. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, and various government entities. The funding will support clinical research over a maximum of four years, with an annual budget cap set at $650,000. Applications must demonstrate the rarity of the condition being studied and the proposed trial's potential to provide significant data for product approval. Key application dates include submission deadlines and specific requirements for obtaining approvals, and strict guidelines for compliance must be followed throughout the application process. This FOA demonstrates FDA’s commitment to expedite drug development for rare diseases and actively involves patient input to enhance trial feasibility and design.
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