FDA Watch Podcast

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Recent Episodes

  • Vaccines, Pharmaceutical Policy & FDA’s Next Moves

    Wayne chats with Deb Autor and Paul Offit, M.D., about vaccine development, policy, testing, and funding, including COVID vaccines; the new Commissioner’s National Priority Voucher Program; the Sarepta gene therapy episode; leadership transitions at CDER and CBER; AI in pharmaceutical regulation; and much more. Listen ⇢

    Vaccines, Pharmaceutical Policy & FDA’s Next Moves

  • FDA’s Past, Present & Future with John Taylor

    Wayne chats with former FDA leader and industry veteran John Taylor about the most pressing issues FDA is facing in drugs, devices, foods, and cosmetics; the agency’s increasing use of AI; what FDA’s top priorities should be moving forward; and much more. Listen ⇢

    FDA’s Past, Present & Future with John Taylor

  • The Top 3 Developments of 2025 in Pharma, Devices, Cosmetics & Food

    Shelly and Wayne chat with Naomi Lowy, M.D., Claire Davies, Angela Diesch, and Frank Yiannas about their top three FDA developments from the first half of 2025 in their respective areas. Listen ⇢

    The Top 3 Developments of 2025 in Pharma, Devices, Cosmetics & Food

  • Breaking Down Cosmetics Safety, Imports & MoCRA

    Shelly and Wayne chat with PCPC’s Emily Manoso about the state of cosmetics regulation and safety under the new administration, cosmetic and personal care product imports, the implementation and enforcement of MoCRA, FDA’s fragrance allergen labeling rule, and much more. Listen ⇢

    Breaking Down Cosmetics Safety, Imports & MoCRA

  • AI, Medical Products & FDA, Part 3: AI in Drug & Device Commercialization

    In the final part of our AI series with Arnold & Porter, Shelly and Wayne chat with Philip Desjardins, Mahnu Davar, and William Maisel about the use of AI for clinical decision support, AI’s impact on advertising and promotion, “AI washing,” FDA’s first AI-assisted scientific review pilot, and much more. Listen ⇢

    AI, Medical Products & FDA, Part 3: AI in Drug & Device Commercialization

  • Homing in on Food Supply, Tariffs & Infant Formula

    Shelly and Wayne chat with Martin Hahn and Tony Pavel about global food supply chain vulnerabilities; how U.S. tariffs on imported food products influence the availability and safety oversight of essential goods; how FDA is working with international partners to improve transparency; FDA measures to ensure a more resilient infant… Listen ⇢

    Homing in on Food Supply, Tariffs & Infant Formula

  • AI, Medical Products & FDA, Part 2: AI Discovery, Design & Development

    In part two of our AI series with Arnold & Porter, Shelly and Wayne chat with Howard Sklamberg, Eva Temkin, and Marko Topalovic about how AI can accelerate drug discovery and design and be used in clinical trials, how FDA could use AI to evaluate manufacturers’ data integrity operations, and… Listen ⇢

    AI, Medical Products & FDA, Part 2: AI Discovery, Design & Development

  • Devices, Disruption & the Road Ahead

    Shelly and Wayne chat with Dr. Daniel Schultz and Jonathan Kahan about the effect of CDRH staff reductions on medical device reviews and market authorizations, how FDA is responding to device shortages and supply interruptions, the effectiveness of the current post-market surveillance system in detecting device-related adverse events, and much… Listen ⇢

    Devices, Disruption & the Road Ahead

  • Breaking Down Pharma in the Current Environment

    Shelly and Wayne chat with Dr. Michelle McMurry-Heath and Alan Minsk about the potential effects that FDA staffing cuts may have on drug and biologics approvals; how the current environment may affect investments in drug and biotech development; how FDA can aim to include all demographics of patients in trials;… Listen ⇢

    Breaking Down Pharma in the Current Environment