ALS Reauthorization Act Becomes Public Law 119-138
The Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 was enacted on November 3, 2026, extending programs through fiscal year 2031.
The Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 became Public Law 119-138 on November 3, 2026.
The act reauthorizes programs through fiscal year 2031.
The act reauthorizes NIH grants for research on investigational ALS drugs, FDA grants for development of ALS and neurodegenerative disease therapies, and a public‑private partnership of the FDA and NIH that supports development and regulatory review of such treatments.
The NIH must assess safety and efficacy data when renewing grants and require grantees to report serious unexpected adverse events promptly; the FDA must publish a five‑year plan to foster development and access to ALS drugs and a report on actions taken under that plan.
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Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 (Public Law 119-138)
The Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 (H.R. 8205) became Public Law 119-138 on November 3, 2026.
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Facts this version was allowed to use
- The Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 (H.R. 8205) became Public Law 119-138 on November 3, 2026.
- The Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 was enacted as Public Law 119-138.
- The act reauthorizes programs through fiscal year 2031.
- The act revises programs supporting research and development of drugs and other therapies for amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease) and other neurodegenerative diseases.
- The act reauthorizes grants from the National Institutes of Health (NIH) for scientific research on investigational drugs to prevent or treat ALS for individuals not otherwise eligible for clinical trials.
- The act reauthorizes grants from the Food and Drug Administration (FDA) for research and development of therapies to prevent and treat ALS and other neurodegenerative diseases.
- The act reauthorizes a Public-Private Partnership including the FDA and NIH that supports development and regulatory review of treatments for neurodegenerative diseases.
- The NIH, in considering renewal of its grants, must assess available information on the safety and efficacy of the investigational drugs.
- The NIH must require grantees to promptly report serious and unexpected adverse events associated with their investigational drugs.
- The FDA must publish a plan describing actions it will take over a five-year period to foster development of safe and effective drugs, and facilitate access to investigational drugs, that treat ALS and other rare neurodegenerative diseases.
- The FDA must publish a report describing the actions it has taken under the plan.
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