Abstract
Presentation Description :
This presentation describes the current state of gene therapies, from the perspective of the Director, Division of Clinical Evaluation and Pharmacology / Toxicology, Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), United States Food and Drug Administration (FDA). Topics covered include regulatory perspectives on the challenges and successes that have been seen with gene therapies for a variety of indications, including ophthalmologic disorders.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.