Patricia Hughes CDER, FDA


Patricia F. Hughes received a Ph.D. in Microbiology from Georgetown University and is currently the Branch Chief (acting) in Branch IV of the Division of Microbiology Assessment, Office of Process and Facilities, Office of Product Quality in CDER. This branch is responsible for the microbiology product quality oversight of all CDER BLA submissions and for the pre-license and pre-approval inspections of biological manufacturing facilities, both domestic and foreign. Dr. Hughes has over twenty years of industry experience in process development and manufacturing and has held various positions in the biotech industry ranging from Senior Scientist to Associate Director of Pharmaceutical Operations. She has been with the FDA for over 19 years and has held various positions in both CDER and CBER as a primary reviewer, lead inspector, team leader and branch chief.