Speaker Profile
J.D., Chief of Staff to the Commissioner, U.S. Food and Drug Administration
Biography
Lauren Silvis serves as the Chief of Staff to FDA Commissioner Scott Gottlieb, M.D. In this capacity, she provides advice and counsel to the Commissioner and acts as the Commissioner’s direct liaison to other agencies and organizations on key initiatives. She also works closely with the agency’s individual product centers to support their implementation of agency policy and commitments. She provides strategic direction to senior leadership to advance agency priorities. Ms. Silvis has deep expertise in all aspects of the Federal Food, Drug and Cosmetic Act and the oversight of FDA-regulated products. She has significant experience in regulatory and compliance issues, including clinical trials, premarket review and approval, product safety and promotion, import and export, and current good manufacturing practice. Before being appointed Chief of Staff, Ms. Silvis served as Deputy Center Director for Policy in FDA’s Center for Devices and Radiological Health. In this role, she led the development and implementation of all medical device policies, regulations, and guidance, and oversaw the Center’s communication and education functions. She regularly advised on regulatory, programmatic and legislative issues affecting medical devices and represented the Center on cross-cutting Agency policy issues. Prior to joining FDA in 2015, Ms. Silvis was a partner practicing food and drug regulatory law at a large international law firm. She graduated cum laude from Duke University and earned her law degree cum laude from Georgetown University Law Center, after which she served as a law clerk to the Honorable James L. Ryan, U.S. Court of Appeals for the Sixth Circuit.
