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    Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required

    Funds clinical trials for new treatments or labeling changes for rare neurodegenerative diseases in adults and children, aiming to increase FDA-approved therapies.

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    Funder: Food and Drug Administration

    Due Dates: Forecasted for FY2025 | Estimated due date not yet posted

    Funding Amounts: Award ceiling: $900,000 | Award floor: $650,000 | Single-year R01 clinical trial support

    Summary: Supports clinical trials evaluating new treatments or labeling changes for rare neurodegenerative diseases in adults and children to increase FDA-approved therapies.

    Key Information: This is a forecasted opportunity; application details and deadlines are forthcoming.


    Description

    This funding opportunity from the Food and Drug Administration (FDA) is designed to support clinical trials that address unmet needs in rare neurodegenerative diseases affecting both children and adults. The goal is to fund studies evaluating the efficacy and/or safety of products in support of a new indication or a change in labeling, ultimately increasing the number of FDA-approved treatments for these conditions. The FDA encourages collaborative, efficient, and innovative clinical trial designs that can have a broad and positive impact on rare disease drug development.


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