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Recent Episodes
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FDA’s Evolving Approach to Medical Device Reviews
Wayne chats with Mike Ryan and Michael Gaba about the relationship between FDA and the device industry; factors that influence how reviewers assess risk, credibility, and readiness during submission reviews; the role of the TPLC approach at CDRH; FDA’s elimination of the requirement that RWE submissions include identifiable patient-level information;… Listen ⇢
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Inside FDA Pharma Policy Development
Wayne chats with Rumi Young and Jamie Gamerman about how FDA policy is developed, how previous PDUFAs have changed the agency’s policy agenda, the most important inflection points driving FDA policy, the development of new agency frameworks, FDA’s efforts to balance scientific integrity with regulatory flexibility in policy development, and… Listen ⇢
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Year-End Review & a Look Ahead
Wayne chats with Paul Kim, John Sawyer, Stuart Pape, and Angela Diesch. Each guest dives into the top FDA developments from 2025 in their respective areas, as well as the top developments to watch for in 2026. Listen ⇢
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Deregulation, AI & More with Dr. Ritu Nalubola
Wayne chats with Dr. Ritu Nalubola about how deregulation has been playing out at FDA, industry incentive programs, how agency efforts to streamline regulation could affect product safety, the agency’s role in regulating AI and supporting AI applications, broader initiatives on health data and governance, where things may be headed… Listen ⇢
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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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