A Look at FDA's Drug Review Reset – FDA Watch
Wayne chats with Dr. Cartier Esham, CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA, and Elizabeth Jungman, Partner at Hogan Lovells in the firm’s Pharmaceuticals and Biotechnology practice. You’ll hear their thoughts on FDA’s maintenance of its drug review process amid staffing cuts; the agency’s new PreCheck program and how it may proceed; FDA’s evolving stance on confirmatory evidence and accelerated approvals and how they could reshape how companies approach clinical trial designs or risk disclosures; agency budgets; ramped-up AI use at the agency and in industry; and much more.
Headlines
Pharma: Former CBER Director Dr. Peter Marks joins Eli Lilly
Devices: FDA seeks public input on how best to measure and evaluate AI-enabled medical devices
Food: FDA continues to investigate Listeria and Salmonella outbreaks across U.S.
Cosmetics: Jury awards $966 million to family of deceased California woman, finding that Johnson & Johnson’s talc-based baby powder contributed to mesothelioma
Resource Links
Cosmetics: FDA launches FAERS Public Dashboard for Cosmetic Products
About Our Guests
Dr. Cartier Esham
Cartier Esham, PhD., is CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA. She is a policy leader, recognized for her advocacy for a science-based FDA regulatory environment.
Before founding Esham Strategies, she was the Chief Scientific Officer and Executive Vice President of the Biotechnology Innovation Organization. In that role, she oversaw multiple BIO departments and was responsible for many of the organization’s public affairs initiatives. Dr. Esham holds a Ph.D. in Microbiology from the University of Georgia.
Elizabeth Jungman
Elizabeth Jungman is a Partner at the global law firm Hogan Lovells, where she is part of the firm’s Pharmaceuticals and Biotechnology practice. Prior to joining Hogan, Elizabeth served in senior roles across the U.S. Food and Drug Administration (FDA), Capitol Hill, and the nonprofit sector.
At the FDA, Elizabeth served as Chief of Staff to the FDA Commissioner where she oversaw the day-to-day management of the agency and provided strategic counsel to agency leadership. Prior to that role, Elizabeth led policy for FDA’s Center for Drug Evaluation and Research (CDER) where she was the Associate Center Director for Policy and Director of CDER’s Office of Regulatory Policy (ORP). In these roles Elizabeth advised the Center Director and other senior officials on drug policy development, implementation, and long-range program strategy. She helped oversee the development of regulations, policies, and procedures affecting nearly every aspect of CDER.
Before joining CDER, Elizabeth was the Director of Public Health Programs at the Pew Charitable Trusts. She has also served as Senior Health Policy Adviser with the U.S. Senate Committee on Health, Education, Labor, and Pensions, where she was the Senate lead in drafting and negotiating the FDA Safety and Innovation Act of 2012 and other health- and drug-related legislation, including, pandemic preparedness, drug compounding, and supply chain security.
Elizabeth earned her bachelor’s degree in biology from Harvard College, law degree from Georgetown University, and has a master’s degree in public health from Johns Hopkins.
FDA Watch Podcast 