Leslie Kux is Associate Commissioner for Policy and Director of the Office of Policy in the Office of the Commissioner at the Food and Drug Administration (FDA).
Ms. Kux advises the Commissioner and FDA leadership on a broad range of agency policy issues, as well as regulations and guidance development. She is FDA's focal point for developing cross-cutting agency policy and the agency's liaison for intergovernmental policy development. She oversees, directs, and coordinates the agency's rulemaking activities and regulations development system, including processing documents for publication in the Federal Register and initiating new systems and procedures to make the agency's rulemaking process more efficient.
Ms. Kux received her law degree in 1986 from the George Washington University Law School. Before joining FDA, Ms. Kux practiced food and drug law in private practice. She started her career with FDA in 1988 in the Office of Chief Counsel. During her tenure in OCC, she handled litigation and counseling matters on a wide rage of issues, including devices, food safety and labeling, veterinary products, imports, and international trade. From 2006 – 2010, she was Deputy Director of the Office of Compliance and Biologics Quality in FDA's Center for Biologics Evaluation and Research.