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Recent Episodes
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Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs
In Part 3 of our series with Hyman, Phelps & McNamara, Wayne chats with Sara Koblitz, Kurt Karst, and Karin Hessler about hurdles facing generic drugs in today’s regulatory environment; pressure on industry to continue lowering drug prices; how Hatch-Waxman has played out over the past 40 years; how tariffs… Listen ⇢
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Pharmaceutical Regulation, Compliance & Policy, Part 2: Navigating the New Enforcement Environment
In Part 2 of our series with Hyman, Phelps & McNamara, Wayne chats with John Claud, Peter Dickos, and Andrew Hull about the current enforcement environment at FDA; foreign inspections of pharmaceuticals and how companies should respond to 483s; False Claims Act theories for liability; key considerations for consent decrees… Listen ⇢
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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 ⇢
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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 ⇢
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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 ⇢
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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 ⇢
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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 ⇢
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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 ⇢
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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 ⇢
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