Douglas Stearn is currently serving as the deputy director for regulatory affairs in the Office of Regulatory Affairs (ORA) in the U.S. Food and Drug Administration (FDA). In this position, he has responsibilities in overseeing inspections, import operations, criminal investigations, laboratory testing, and other field activities across all FDA-regulated commodities. Mr. Stearn has been with FDA for over 15 years. His numerous leadership positions within FDA include deputy director for regulatory affairs in the Center for Food Safety and Applied Nutrition (CFSAN), director of ORA’s Office of Enforcement and Import Operations, deputy director for policy and analysis in the Office of Compliance in the Center for Drug Evaluation and Research (CDER), and director of ORA’s Division of Compliance Policy. At CFSAN, he oversaw activities involving foodborne outbreaks and emergency response, inspection and sampling assignments, enforcement, and cooperative programs. In his previous executive position at ORA, he oversaw all import operations and was instrumental in establishing a dedicated workforce for import work, as well as serving as the central lead for ORA on significant enforcement issues across the agency. At CDER’s Office of Compliance, he oversaw the office’s analytical team, regulatory policy engagement, and novel enforcement cases. Before joining the FDA, Mr. Stearn served as a trial attorney for 15 years at the U.S. Department of Justice, where he handled numerous civil and criminal cases involving the FDA. His cases involved a wide range of topics, including falsification of data in drug applications and manufacturing, food safety, failures to report or fully address adverse events in medical devices, misuse of animal drugs, various types of fraud aimed at consumers, and market entry issues for generic drugs.