AI-washing – when AI hype becomes a litigation risk
Elizabeth Jungman
Partner Global Regulatory
Elizabeth helps clients navigate complex FDA interactions, develop efficient regulatory pathways, prepare for and conduct critical meetings, respond to review team disagreements, elevate issues within the agency, and challenge adverse determinations. Her work also includes advising on evolving FDA review standards and pathways, evidentiary and procedural flexibilities, supply chain security requirements, product jurisdiction and combination‑product issues, and commercialization planning.
Elizabeth brings more than two decades of experience in senior roles at the FDA, on Capitol Hill, and in the nonprofit sector, providing clients with practical, strategic guidance grounded in a deep understanding of how FDA decision‑making works in practice. Prior to joining the firm, she served as Chief of Staff to the FDA Commissioner, overseeing day‑to‑day agency operations and advising FDA leadership on strategic and policy matters. Earlier in her career, she held senior leadership roles within FDA’s Center for Drug Evaluation and Research (CDER), including Associate Director for Policy and Director of the Office of Regulatory Policy, where she advised senior officials on drug policy development and implementation.
Before joining FDA, Elizabeth was Director of Public Health Programs at the Pew Charitable Trusts and served as Senior Health Policy Adviser to the U.S. Senate Committee on Health, Education, Labor, and Pensions, where she helped draft and negotiate the FDA Safety and Innovation Act of 2012 and other health‑ and drug‑related legislation.
Elizabeth serves on the boards of the FDA Alumni Association and the Alliance for Safe Online Pharmacies. She holds a bachelor’s degree from Harvard College, a law degree from Georgetown University, and a master’s degree in public health from Johns Hopkins University.