Ekaterina Allen PhD
Regulatory Project Manager and CMC Facilities Reviewer, CBER/FDA
Dr. Allen is currently a Consumer Safety Officer in the Division of Manufacturing and Product Quality, Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research (CBER). She is responsible for review of facility and equipment sections of Biologic License Applications and post-marketing supplements and for conducting pre-license and pre-approval inspections for all CBER-regulated products. Dr. Allen earned her M.S. in Medical Biology from Novosibirsk State University, Russia and her Ph.D. in Pharmacology from the University of Minnesota.