Pharmaceutical Online/Cell & Gene/Bioprocess Online – October 6, 2022

PDUFA VII, CBER and the new gene & cell therapy Super Office: Catalyst’s Nancy Bradish Myers shares her insights on the cleanest user fee reauthorization in 30 years. The big winner of PDUFA VII is the Center for Biologics Evaluation & Research (CBER), and recent events indicate CBER is ready with a plan. Myers explores the dramatic increase in CBER’s resources under the new PDUFA, the Center’s reorganization of its gene & cell therapy review office into a new “Super Office” and the implications for gene & cell therapy innovators.

Read full article: FDA User Fee Programs Reauthorized: FDA’s CBER Is A Clear Winner