FDA Public Workshop on Clinical Trials Involving Cell or Gene Therapy in Pediatric Populations (Nov. 2)
This post was written by Paul Sheives.
FDA will hold a public workshop on November 2, 2010 to seek input on best practices related to cell and gene therapy clinical trials in pediatric populations. A panel will discuss topics including: (1) evaluating cell and gene therapy products prior to initiating pediatric clinical studies; (2) identifying and minimizing risks associated with the administration of cell and gene therapy products in pediatric populations; (3) obtaining informed consent and assent; and (4) conducting continuing review of cell and gene therapy products in pediatric populations. Registration for the meeting closes on October 1, 2010.
