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# Gene Therapy for Neurodegenerative Diseases Guidance
- URL: https://www.fdaweb.com/gene-therapy-for-neurodegenerative-diseases-guidance-2/
- Published: 2021-01-06T12:00:00.000Z
- Updated: 2026-09-14T16:41:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148389

*Federal Register* notice: FDA has made available a draft guidance entitled *Human Gene Therapy for Neurodegenerative Diseases*. The document provides recommendations for sponsors developing human gene therapy products for neurodegenerative diseases affecting adult and pediatric patients. It defines neurogenerative diseases as a heterogeneous group of disorders characterized by progressive degeneration of the structure and function of the central nervous system or peripheral nervous system. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-01-06/pdf/2020-29238.pdf?ref=fdaweb.com).