Zhihao (Peter) Qiu

Dr. Qiu is an Acting Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER, FDA. The Division oversees the scientific assessment and quality evaluation of the manufacturing and control (e.g. sterility assurance and microbiological control) and facilities for Biologic License Applications (BLA), Investigational New Drugs (IND), supplemental BLAs, and DrugMaster Files (DMF). The Division is also responsible for conducting pre-license inspections for CDER regulated BLAs. Prior to his current position, he was an acting Division Director in the Division of Microbiology Assessment and a Branch Chief in the Division of Inspectional Assessment, Office of Process and Facilities, CDER. He joined CDER as Branch Chief in the Biotech Manufacturing Assessment Branch in the Office of Compliance, where he managed the microbiology review and pre-license inspection program for CDER regulated BLAs. Dr. Qiu joined FDA as a facility reviewer and pre-license inspection investigator in the Office of Compliance and Biologic Quality, CBER. He then joined the Center for Devices and Radiological Health (CDRH) as an Associate Director in the Division of Chemistry and Toxicology Devices. At CDRH, he was responsible for managing pre-market review for Class II and Class III toxicology devices. He also served as the lead compliance officer for the Division’s postmarket program including recalls, EIR reviews, inspections, and warning letters. Dr. Qiu obtained his Ph.D. degree in Biological Sciences from the University of Southern California.