Michael J. Popek FDA

Mr. Popek has been with the Center for Veterinary Medicine (CVM) since 2001. He started as a Review Microbiologist in the Division of Manufacturing Technologies (DMT) Antimicrobial Team and then became Supervisory Microbiologist of the Biotherapeutics Team in 2005. The Biotherapeutics Team reviews the chemistry, manufacturing, and controls technical sections for biotechnology, Minor Use and Minor Species (MUMS), phage, competitive exclusion, etc. products submitted in new animal drug applications (NADA). CVM's DMT requests PAI inspections, provides scientific support during inspections, reviews foreign 483 responses, and provides post-PAI support for compliance issues. He holds a B.S. in Biological Sciences (Molecular Genetics) from The Ohio State University, and a M.S. in Microbiology from the University of Maryland, College Park.