FDA Watch Podcast

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Recent Episodes

  • FDA’s Fight Against Ultraprocessed Foods

    Wayne chats with Claudia Lewis and Ricardo Carvajal about FDA’s focus on ultraprocessed foods; GRAS regulation and former FDA Commissioner Kessler’s citizen petition; potential agency updates to food nutrition labeling; inspections and food safety; FDA’s use of AI in food decision-making; and much more. Listen ⇢

    FDA’s Fight Against Ultraprocessed Foods

  • Dissecting the Direction of CDER and CBER with Paul Kim

    Wayne chats with Paul Kim about major legal concerns with what FDA is aiming to accomplish; priorities for CDER Director Dr. George Tidmarsh and CBER Director Dr. Vinay Prasad; the direction of CDER and CBER on orphan drugs, rare diseases, and vaccines; reviews under the Commissioner’s National Priority Voucher Program;… Listen ⇢

    Dissecting the Direction of CDER and CBER with Paul Kim

  • Medical Device Oversight in a Changing Landscape

    Wayne chats with Neil O’Flaherty and Bobbi Druyor-Sanchez about what’s happening at CDRH with warning letters and inspections for medical devices, AI-enabled medical devices and the ongoing situation with Whoop, and much more. Listen ⇢

    Medical Device Oversight in a Changing Landscape

  • 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