Mark J Goldberger
22 August 2019
Dr Goldberger received his MD degree from the Columbia University College of Physicians and Surgeons in New York and his MPH from George Washington University in Washington, DC. He completed his postgraduate training at the Presbyterian Hospital in New York and the Centers for Disease Control (CDC) in Atlanta. He is board certified in internal medicine and infectious disease and is a fellow of the Infectious Diseases Society of America. Dr Goldberger was on the faculty of Columbia University for nine years. He joined the Food and Drug Administration in 1989. At the FDA he served as primary reviewer, medical team leader, Director of the Division of Special Pathogen and Immunologic Drug Products and Director of the Office of Antimicrobial Products within the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA). In addition to these positions he coordinated drug shortage activities within the CDER from 1990 - 2006. Dr Goldberger also was the FDA lead in an assessment of the readiness of the Pharmaceutical Industry for Y2K. In 2000 he spent 8 months as acting Associate Center Director for Quality Assurance in CDER during which time he developed the concept of the Regulatory Briefing. In 2003-2004 he was Acting Deputy Center Director of CDER. In 2006 he became Medical Director for Emerging and Pandemic Threat Preparedness within the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration.
In October 2007 he joined Abbott as Divisional Vice President – Regulatory Policy and Intelligence. In this role he was involved in multiple areas of both product and policy development. He continued in this position when AbbVie separated from Abbott until May 2013 when he became VP Regulatory Affairs and Senior Advisor. In this position he provided regulatory and scientific input both into multiple development programs and in the preparation of marketing applications. In September 2014 he retired from AbbVie and opened his own consulting practice as Mark Goldberger MD MPH LLC.