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    Brian Malkin Guest Lectures at Georgetown University Law Center

    On October 6, 2017, Arent Fox FDA and Health Care Counsel Brian Malkin taught a Health Law and Regulation class at Georgetown University Law Center. The class covered the progression of clinical trials for newly-developed drugs and the role FDA plays in the process from application to testing to the approval for a drug to be marketed and sold to the public. Brian’s lecture contained a very detailed overview of risk evaluation and mitigation strategies (REMS) as an additional safety measure FDA may consider in addition to product labeling. He also discussed the ins and outs of the enforcement of FDA’s rules and regulations in the US for both clinical trials and marketed products and manufacturing facilities, as well as provided an overview of how FDA regulates imports and exports and the international harmonization efforts currently underway with FDA and other regulatory bodies.