A review of FDA requirements, regulations and challenges.
Key Learning Objectives:
•Understanding intended use
• What is necessary for compliance
• What will get you into trouble
Target Audience: Supplier, Distributor
John Fuson is a member of Crowell & Moring’s Advertising & Product Risk Management, Health Care, and White Collar and Regulatory Enforcement groups, specializing in U.S. Food and Drug Administration (FDA) enforcement and counseling matters. Before joining Crowell & Moring, John served as associate chief counsel at FDA, with broad law enforcement responsibilities, from 2007-2012. At FDA, John handled all types of major enforcement actions brought by the agency, including seizure actions, injunction actions, actions for civil money penalties, and contempt actions. His cases have involved drugs, devices, food, and veterinary drugs. John is a frequent speaker on FDA enforcement practices and has written extensively on food policy. He received his undergraduate degree from Grinnell College, and his law degree from the University of Pennsylvania.