FDA Watch Podcast

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Recent Episodes

  • A New Era of Unprecedented Change

    Shelly and Wayne chat with Nancy Myers, CEO of Catalyst Healthcare Consulting, and Stuart Pape, Senior Partner and Chair of the FDA Practice at Polsinelli, about what companies should be doing now amid changes at FDA, including the recent confirmation of Dr. Marty Makary as the agency’s new commissioner; the… Listen ⇢

    A New Era of Unprecedented Change

  • The Latest in FDA’s Focus on Foods

    Shelly and Wayne chat with Dr. Susan Mayne and Dr. Peter Lurie about why it took FDA so long to ban Red Dye No. 3, the agency’s “healthy” claim final rule, where FDA stands with reducing sodium in human foods, the push to eliminate the self-affirmed GRAS pathway, and much… Listen ⇢

    The Latest in FDA’s Focus on Foods

  • What’s Happening in Software and Device Regulation

    Shelly and Wayne chat with Jennifer Newberger and Michael Gaba about anticipated changes in the review and approval of PMAs, 510ks, and de novo applications; clinical trial requirements for SaMD; and much more. Listen ⇢

    What’s Happening in Software and Device Regulation

  • 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 ⇢

    The Evolution of Clinical Trials

  • 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 ⇢

    Navigating FDA’s Future: Janet Woodcock on the Evolving Regulatory Landscape

  • 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 ⇢

    A Deep Dive Into MoCRA

  • 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 ⇢

    Food Regulation and Safety Under the New Administration

  • 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 ⇢

    The New-Look FDA: What’s on the Horizon?

  • 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 ⇢

    What’s Coming in Device, Cybersecurity, and Digital Health Product Regulation