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FDA formalizes new partnership to advance neurodegenerative disease research

The FDA took further steps toward a comprehensive approach to rare neurodegenerative diseases on September 14, announcing a public-private partnership among the FDA, National Institutes of Health, and the nonprofit Critical Path Institute (C-Path). C-Path will serve as the convener for efforts including patient-focused drug development and speeding the development of therapies by use of the FDA’s rare disease accelerator and analytics platforms.

Background on the ACT for ALS Act

  • The Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act (ACT for ALS) was enacted on December 23, 2021. ACT for ALS provides for grants for ALS research, calls for establishing public-private partnerships to advance disease understanding and drug development for rare neurodegenerative diseases, and directs the FDA to publish a 5-year action plan laying out operational plans for accomplishing the goals of ACT for ALS.

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