H.R.8205

Reauthorizes the Accelerating Access to Critical Therapies for ALS Act through fiscal year 2031.

The Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 extends the provisions of the Accelerating Access to Critical Therapies for ALS Act through fiscal year 2031. It amends the definition of "phase 3" clinical trials to include phase 2/3 combined trials and planned phase 3 trials not yet enrolling participants. The bill also mandates the Food and Drug Administration to publish a report detailing actions taken under the 2022 Action Plan, the impact on therapy development for ALS and other rare neurodegenerative diseases, and approaches for better coordination with.