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’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.

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’s 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.

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Music by Dvir Silver from Pixabay.