FDA - Human Gene Therapy for Neurodegenerative Diseases Guidance for Industry (Cell and Gene Therapy Catapult - Regulatory Round-up – October 2022)
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25 janvier 2023
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- handle: 10670/1.h86jwz
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adelage, « FDA - Human Gene Therapy for Neurodegenerative Diseases Guidance for Industry (Cell and Gene Therapy Catapult - Regulatory Round-up – October 2022) », ELSIBI, ID : 10670/1.h86jwz
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The guidance, issued in October 2022 by the Center for Biologics Evaluation and Research, provides recommendations to sponsors developing human gene therapy (GT) products for neurodegenerative diseases affecting adult and pediatric patients. This guidance finalises the draft guidance of the same title dated January 2021. See all of Catapult's Regulatory Round-up for October 2022 here. Published on the 7th of November 2022.