2022-23057: Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry." Neurodegenerative diseases are a heterogeneous group of disorders characterized by progressive degeneration of the structure and function of the central nervous system or peripheral nervous system. The guidance document provides recommendations to sponsors developing human gene therapy (GT) products for neurodegenerative diseases affecting adult and pediatric patients. The guidance focuses on considerations for product development, preclinical testing, and clinical trial design. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2021.
The agency’s own summary, as published.
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