Michael Smedley FDA

Michael Smedley, Deputy Director, Office of Manufacturing and Product Quality, OC, CDER, FDA. Mike began his career at FDA 26 1/2 years ago as a Chemist in the Center of Veterinary Medicine (CVM). His 17 years of CVM experience included (1) enforcement and surveillance issues in the Office of Surveillance and Compliance, (2) Chemistry Reviewer and CGMP Pre-Approval Program Manager in the Office of New Animal Drug Evaluation, and (3) Research Chemist in the Office of Research. He joined CDER’s Office of Compliance in 2003 as the Branch Chief, Therapeutics Facilities Review Branch during the transition of the therapeutic biologics from CBER to CDER. He later served as Branch Chief, Recalls and Shortages Branch, where he markedly improved branch management systems and response to recall alert notifications. In 2009-2011, he served as Deputy Division Director of DMPQ. Since 2011, he has served as the Deputy Office Director of OMPQ, where he assists the Office Director with oversight of all office functions, including preapproval and surveillance inspection compliance programs, enforcement strategy, BLA/NDA/ANDA pre-approval facility evaluation, manufacturing policy, product defects, and administrative operations. Since January of 2013, Mike has been serving as the acting Office Director of OMPQ. He received his BS in Biochemistry from VA Tech.