Docket Number:
FDA-2018-D-2236
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance provides recommendations to sponsors developing human gene therapy (GT)  products for retinal disorders affecting adult and pediatric patients.  These disorders vary in etiology, prevalence, diagnosis, and management, and include genetic as well as age-related diseases.  These disorders manifest with central or peripheral visual impairment and often with progressive visual loss.  This guidance focuses on issues specific to GT products for retinal disorders and provides recommendations related to product development, preclinical testing, and clinical trial design for such GT products. This guidance finalizes the draft guidance of the same title dated July 2018.

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