CBER leaning into gene therapy 

Increasing the number of gene therapy approvals, including by opening the accelerated approval pathway to gene therapies, helping to reduce manufacturing costs, and enhancing global regulatory collaboration are priorities for FDA, Peter Marks, director of the agency’s Center for Biologics Evaluation and Review, said this week.

Speaking on a webinar sponsored by the Alliance for a Stronger FDA, Marks also provided updates on the CBER’s establishment of a the Super Office of Therapeutic Products (SOTP) and on plans to launch an “Operation Warp Speed-like” initiative for rare diseases. ...