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H.R. 8205

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

📅 Jul 09, 2026
Summary:
• Extends the authorization of the Accelerating Access to Critical Therapies for ALS Act through fiscal year 2031 (previously authorized through 2026)
• Requires clinical trial status reviews for grant renewals, including assessment of patient enrollment data and requests for interim clinical trial data from manufacturers
• Mandates the FDA Commissioner to publish a report within one year containing an updated 5-year action plan and a review of the 2022 Action Plan implementation
Additional Details:
• Expands the definition of "phase 3" clinical trials to include phase 2/3 combined trials and planned phase 3 trials not yet enrolling participants
• Requires the GAO to submit a report to congressional committees within 4 years containing analyses and data as described in the original Act
• Includes provisions for improved coordination with rare neurodegenerative disease communities beyond ALS and expresses Congressional support for direct appropriation of funds

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