FDA lays out plan to boost gene therapy approvals
The FDA has approved 12 gene therapies so far, and the agency's top drug regulator wants to see the road ahead illuminated with green lights.
If the FDA only approves two or three per year over the next few years, Peter Marks, M.D., head of the FDA’s Center for Biologics Evaluations and Research (CBER), says "that’s a failure.” His comments came at a webinar Tuesday hosted by the Alliance for a Stronger FDA, a lobbying group for the agency.