Director, Division of Case Management, FDA/CBER/OMPT/OCBQ
Mr. Robert Sausville is Director, Division of Case Management (DCM) Office of Compliance and Biologics Quality, at FDA’s Center for Biologics Evaluation and Research (CBER). DCM is responsible for enforcement actions of CBER regulated products, review of advertising and promotional labeling material and all CBER recalls. Prior to joining DCM, Mr. Sausville spent eight years in CBER’s Division of Manufacturing and Product Quality where his responsibilities included review of establishment and biologics license applications and supplements related to viral vaccines, monoclonal antibodies, in-vitro diagnostic kits and plasma fractionation products, as well as inspection of manufacturing facilities. Mr. Sausville started his FDA career in what is now the Division of Emerging Transfusion Transmitted Diseases in the Office of Blood Research and Review.