{"version":1,"type":"rich","provider_name":"Libsyn","provider_url":"https:\/\/www.libsyn.com","height":90,"width":600,"title":"A Look at FDA\u2019s Drug Review Reset","description":" Wayne chats with 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\u2019s Pharmaceuticals and Biotechnology practice. You\u2019ll hear their thoughts on FDA\u2019s maintenance of its drug review process amid staffing cuts; the agency\u2019s new PreCheck program and how it may proceed; FDA\u2019s 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. In our headlines segment, Wayne delves into these major developments: 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\u2019s talc-based baby powder contributed to mesothelioma In our Resource Links segment, we list key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.  Music by Dvir Silver from Pixabay. ","author_name":"FDA Watch","author_url":"https:\/\/sites.libsyn.com\/557121","html":"