FDA Watch Podcast

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Recent Episodes

  • A Look at FDA’s Drug Review Reset

    Wayne chats with Dr. Cartier Esham and Elizabeth Jungman about FDA’s maintenance of its drug review process amid staffing cuts; the agency’s new PreCheck program and how it may proceed; FDA’s evolving stance on confirmatory evidence and accelerated approvals; agency budgets; AI use at the agency and in industry; and… Listen ⇢

    A Look at FDA’s Drug Review Reset

  • Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases

    In Part 1 of our series in collaboration with Hyman, Phelps & McNamara, P.C., Wayne chats with James Valentine, Frank Sasinowski, Louise Himmelstrup, and Kate McCurdy about the current status of orphan drug approvals at FDA; confirmatory evidence in rare disease development programs, how sponsors and FDA are engaging with… Listen ⇢

    Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases

  • Unpacking OMUFA

    Wayne chats with Meredith Petillo about the recent FDA warning letters to sunscreen brands; “foodification” risks in beauty and personal care products; how companies can prepare for potentially increased agency focus on non-traditional product formats; OMUFA and how it could impact innovation in the OTC space; and much more. Listen ⇢

    Unpacking OMUFA

  • 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