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Recent Episodes
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Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products
In this final part of our series with Hyman, Phelps & McNamara, Wayne chats with Michelle Butler, Charles Raver, and Josephine Torrente about potential avenues to resolve a disagreement informally, how the formal dispute resolution (FDR) process works, what constitutes a win, what changes may be coming to to the… Listen ⇢
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Key Issues Shaping Cosmetics and Personal Care Oversight
Wayne chats with Rachel Raphael and Ronie Schmelz about what’s happening at FDA in cosmetics and personal care products; how companies should navigate ingredient concerns amid federal inaction, aggressive state laws, and stricter foreign regimes; the state of regulation surrounding labeling and advertising and promotion; what to watch for heading into… Listen ⇢
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How Industry Is Adapting to FDA’s Food Shifts
Wayne chats with Sarah Sorscher and Sarah Gallo about the current state of foods at FDA, concerns related to the agency’s budget, impacts of the government shutdown on the Human Foods program, how federal regulation might affect state regulation, changes to the GRAS process and post-market review, how industry is… Listen ⇢
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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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