Justin Coen, JD

Justin Coen is a partner in Venable’s FDA law group, where he guides companies through the complexities of drug, biologic, and device development. He advises clients on every stage of product development, pre-and post-approval regulatory compliance, and commercialization strategies. Justin also has extensive experience negotiating research and development agreements, licenses, and purchase contracts, including contracts with the federal government. 

Prior to joining Venable, Justin served as a senior regulatory attorney at the Office of the Staff Judge Advocate (JAG), U.S. Army Medical Research and Development Command (USAMRDC), and he has advised the U.S. Senate Committee on Finance.

Justin works with a range of clients, including pharmaceutical companies, medical device manufacturers, and biotech startups, to help them navigate complex regulatory requirements and achieve their business objectives. His expertise includes evaluating marketing application approaches, marketing exclusivity claims, pre- and post-approval GxP compliance, expedited approval mechanisms, priority review vouchers, product labeling issues, animal rule product development, combination products, and advertising and promotion. He also draws on his experience in healthcare policy to help clients understand and shape potential legislative and regulatory changes and, when necessary, respond to government investigations.