FDA to consolidate CDER drug reviews

FDA announced on Friday that it will consolidate review responsibilities for all new pharmaceutical products at the Center for Drug Evaluation and Research and will strip the Center of Biologics Evaluation and Research of its authority to review drugs. CBER will retain authority over vaccines, gene therapy, xenotransplantation and blood products. The consolidation is intended to promote "efficiency and consistency," CDER deputy director Steve Galson told BioCentury.

"The biotech industry views this as a welcome development," Biotechnology Industry Organization President Carl Feldbaum said. "We don't know all the details and it will take some time to work them out, but we are pleased with the special attention that biologics are getting." The new policy "is a recognition of the importance FDA assigns to biologics and of the need to reduce review times," he added. ...