Rebecca A. Devine, PhD

Becky began consulting in 1999 after leaving the U.S. Food and Drug Administration (FDA). She joined the FDA in 1979 as a Microbiologist, and held various positions in the Center for Biologics Evaluation and Research (CBER) throughout her 20-year FDA career including Associate Director for Policy at CBER. In that position she was responsible for the development and implementation of all regulations, policy and guidance for CBER.  Prior to that she was the Associate Director for Regulatory Policy in the Office of Vaccines Research Review, CBER, a reviewer in the Division of Product Certification, and Branch Chief of the Vaccines and Therapeutic Products Branch. Throughout her CBER tenure and consulting career, she has been involved in the review of license applications, inspections, and quality control of vaccine, therapeutic, biotechnology derived biologicals, and cell and gene therapy products.  Dr. Devine earned her BS and PhD degrees in microbiology from the University of Maryland.  She is currently an active member of the Parenteral Drug Association (PDA), served on the PDA Board of Directors for 12 years, and was chair from 2018-2019.