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FDA, NIH Launch Public-private Partnership For Rare Neurodegenerative Diseases

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The U.S. Food and Drug Administration and the National Institutes of Health or NIH have launched Critical Path for Rare Neurodegenerative Diseases or CP-RND, a new public-private partnership to help people with rare neurodegenerative diseases.

The agencies have selected the Critical Path Institute or C-Path as the convener of the partnership, which aims to accelerate drug development for rare neurodegenerative diseases, including amyotrophic lateral sclerosis or ALS.

The formation of the public-private partnership follows the signing of the Act for ALS into law on December 23, 2021 by President Biden. HHS, through FDA and NIH, was required to establish and implement the partnership not later than one year after enactment.

C-Path will convene the partnership, bringing together experts in rare neurodegenerative diseases, including patient communities, advocacy organizations, and private entities.

The partnership will focus on patient-focused drug development, and utilization of the FDA-funded Rare Disease Cures Accelerator-Data and Analytics Platform or RDCA-DAP to bring together scientific data on rare neurodegenerative diseases.

Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke or NINDS, part of the NIH, said, "This public-private partnership will convene the entire ALS community to develop novel strategies and approaches to therapy development and clinical testing with the goal to finally produce a treatment that stops the tragic progression of ALS."

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