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Tom Bozzo

TOM BOZZO served as director of the office of compliance, within the Center for Biologics Evaluation and Research (CBER), FDA from 1988 through May, 1993. Prior to assuming that position he served in the Center for Drugs and Biologics, office of compliance, as chief, sterile drugs and biologics branch, acting chief, manufacturing and review branch, and director, case guidance branch.

In addition, Mr. Bozzo was an inspector during his entire career at FDA. Mr. Bozzo earned his BS degree in pharmacy from St. John’s University and his Master of Public Health degree from the Johns Hopkins University, School of Hygiene and Public Health. Additionally he was an executive fellow at the University of Southern California Graduate School of Business. Mr. Bozzo is a member of the Food and Drug Law Institute’s oversight committee on Drugs and Biologics and served on the editorial board of “Regulatory Affairs Focus” magazine.

Tom is currently is president of Tom Bozzo Associates, Inc., a consulting firm that provides regulatory, compliance and quality assurance guidance to the Biologics, Tissue Banking and Drug industries.