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Recent Episodes
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Keeping Up with Medical Device Manufacturing and Digital Health
Wayne chats with Cathy Burgess and Michael Gaba about what’s been happening recently at CDRH; key issues for medical device manufacturers, such as QSMR implementation and enhanced cybersecurity requirements; the evolution of digital healht and its impact on clinical decision support technologies and wellness products; what could be next for… Listen ⇢
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An Extensive Breakdown of the Pharmaceutical and Biologics Landscape
Wayne chats with Daniel Kracov and Dr. Gayatri Rao about Operation TrialBlazer; what’s been happening lately with CBER and CDER; the latest in rare diseases and orphan drugs; developments in cell and gene therapy; the Plausible Mechanism Framework; the situation with China and global drug development; and much more. Listen ⇢
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FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade
In the second part of our series with Arnall Golden Gregory LLP, Wayne chats with Luis Arandia Jr. and Allison Raley about rethinking global supply chains in light of the Section 232 tariffs affecting patented pharmaceutical products; common customs and trade compliance issues with imported FDA-regulated goods; legal risk-mapping to… Listen ⇢
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FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement
In this first part of our series with Arnall Golden Gregory LLP, Wayne chats with Gabriel Scannapieco about trends in FDA and DOJ enforcement in 2026; how FDA and DOJ have approached the oversight of GLP-1 drugs; DOJ’s non-prosecution agreement resolutions with Alibaba and AUS Merchant Services and what they… Listen ⇢
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Midyear Review: 2026 So Far & a Look Forward
Wayne chats with Paul Kim and Dr. Susan Mayne about the top FDA developments from the first half of 2026 in several areas, as well as the top developments to watch for in the second half of the year. Listen ⇢
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From Price Strategy to Enforcement Risk
In this third and final part of our series with White & Case and BRG, Wayne chats with Lauren Papenhausen and Edward Buthusiem about pricing-related government enforcement risks and the legal framework; commercialization strategies under heightened enforcement scrutiny; internal investigations and distinguishing isolated issues from systemic compliance failures; board and audit committee oversight of… Listen ⇢
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When Pricing Pressure Reaches the FDA File: Practical FDA Realities
In this second part of our series with White & Case and BRG, Wayne chats with Bethany Hills and Dan Troy about where pricing pressures show up at FDA; how pricing issues affect how companies should think about evidence packages, differentiation claims, and life-cycle expansion; product features that often become… Listen ⇢
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Governmental Policy Levers: Navigating Drug Pricing Across Agencies and Congress
In the first part of our series with White & Case and BRG, Wayne chats with Bethany Hills, Rahul Rao, and John Barkett about FDA and product-strategy decisions that determine future pricing power developments; how certain factors shape market structure in ways that could attract anti-trust scrutiny; the line between lawful regulatory strategy and conduct that regulators or plaintiffs may characterize… Listen ⇢
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FDA’s Regulatory Revisions: Business & Legal Impact on Industry, Part 4 – Consumer Products
In the final part of our series with Skadden, Wayne chats with Rachel Turow, Amy Van Gelder, Brett Fleisher, and Katherine Armstrong about how the regulatory approach to consumer products is evolving; how companies should respond to a broader and increasingly varied policy environment with multiple regulators; what’s happening at… Listen ⇢
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