Zdrowie i gospodarka · 30.01.2020
Human Gene Therapy for Retinal Disorders; Guidance for Industry; Availability
The Food and Drug Administration is announcing the availability of a final guidance entitled "Human Gene Therapy for Retinal Disorders; Guidance for Industry." The final guidance provides recommendations to stakeholders developing human gene therapy (GT) products for retinal disorders affecting adult and pediatric patients. The 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. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2018.