Giuseppe Randazzo

FDA/CDER/OPQ/ONDP
Office Director, OPRO; Acting Office Director,ONDP
Giuseppe Randazzo currently serves as acting Office Director, Office of New Drug Products (ONDP) in the Center for Drug Evaluation and Research (CDER). During his current 14 year tenure at the agency, he spent nearly 7 years in OND, approximately 3 years in compliance focusing on GMPs, and most recently, 4 years in Office of Pharmaceutical Quality. As OPQ was standing up, he served as a transition lead by providing expertise on regulatory matters and business processes pertaining to the pre-approval and post approval drug review. Upon official stand up of OPQ, he became Office Director in the Office of Program and Regulatory Operations (OPRO). He served in this capacity until recently when he transitioned over to ONDP to serve as acting director. Prior to joining the FDA, he taught high school chemistry, worked for Eli Lilly and Company, and was a small business owner. Giuseppe earned his master’s degree from Johns Hopkins University and his BS in Chemistry Education from Pennsylvania State University.