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Recent Episodes
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The Evolution of Clinical Trials
Shelly and Wayne chat with Steve Grossman and Anthony Brogno about how drug development, drug approvals, and clinical trials could be evolving under the new administration’s FDA; priorities in clinical trails for the new FDA Commissioner; and the intersection of budget and the FDA’s use of AI in its review… Listen ⇢
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Navigating FDA’s Future: Janet Woodcock on the Evolving Regulatory Landscape
Shelly and Wayne chat with Janet Woodcock, M.D., former FDA Principal Deputy Commissioner on the agency’s approach to navigating the current regulatory environment; the increasing role of AI in FDA decision-making; the future of the agency’s staffing, resources, and regulatory frameworks; and much more. Listen ⇢
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A Deep Dive Into MoCRA
Shelly and Wayne chat with Will Woodlee and David Lennarz about the top priorities in cosmetics regulation for the next FDA Commissioner and their insights on all things MoCRA. Listen ⇢
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Food Regulation and Safety Under the New Administration
In this episode, Shelly and Wayne chat with Stuart Pape and Domenic Veneziano on the top priorities in food regulation for the next FDA Commissioner, increased FSVP inspections, key issues surrounding food importation, the Human Foods program, and more. Listen ⇢
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The New-Look FDA: What’s on the Horizon?
Shelly and Wayne chat with Marc J. Scheineson and Steven A. Grossman about what to expect from FDA under the new administration, including the transition process, Robert F. Kennedy Jr.’s role, staffing issues, funding, and more. Listen ⇢
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What’s Coming in Device, Cybersecurity, and Digital Health Product Regulation
Hear from our two guests on the top priorities in medical device regulation for the next FDA Commissioner and their insights on laboratory-developed tests, the transition to ISO 13485, cybersecurity, and more. Listen ⇢
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Key Pharmaceutical Regulation Issues for the New Administration
In our first episode, Shelly and Wayne chat with Nikki Reeves, Partner in the FDA & Life Sciences practice at King & Spalding, and Brian Malkin, Associate General Counsel for Regulatory Law at Teva Pharmaceuticals. Listen ⇢
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