FDA Watch Podcast

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Recent Episodes

  • The State of Protection, Innovation & Communication at FDA

    Shelly and Wayne chat with Ron Bartek and Ralph Hall about the overall situation at FDA right now; its impact on agency activities and innovation; what areas will be most impacted; what policy changes might be coming; and much more. Listen ⇢

    The State of Protection, Innovation & Communication at FDA

  • AI, Medical Products & FDA, Part 1: AI Overview in Life Sciences

    In this first part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with guests about Arnold & Porter’s recent survey on AI adoption in life sciences; problems, challenges, and successes in AI adoption in drug and medical device development; where FDA may be hampered in… Listen ⇢

    AI, Medical Products & FDA, Part 1: AI Overview in Life Sciences

  • Examining the Cosmetics Compliance and Enforcement Landscape

    Shelly and Wayne chat with Justin Prochnow, Partner in the Denver office of Greenberg Traurig, about what FDA could be prioritizing in cosmetics under new FDA Commissioner Dr. Marty Makary; compliance and enforcement obstacles with MoCRA implementation; challenges companies are facing from class-action attorneys; the intersection of cosmetics and environmental… Listen ⇢

    Examining the Cosmetics Compliance and Enforcement Landscape

  • 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