FDA Watch Podcast

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Recent Episodes

  • Examining CDRH, Device Innovation & Agency Communication

    Wayne chats with Sandra Cohen Kalter and Steve Silverman about whether CDRH has the resources and cross-agency collaboration it needs to fulfill its regulatory mandate, FDA’s capacity to support innovation amid review pressure and staffing cuts, how companies can find reliable up-to-date regulatory information, FDA’s ability to monitor safety and… Listen ⇢

    Examining CDRH, Device Innovation & Agency Communication

  • 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