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Recent Episodes
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The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development
In this first part of our new series in collaboration with Analysis Group, Wayne chats with Dr. James Signorovitch, Bethany Hills, and Dr. Dilesh Doshi about FDA’s ongoing commitment to rare disease drug development; defining real-world evidence (RWE) in the context of FDA and rare diseases; building representative and trustworthy… Listen ⇢
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What’s Actually Happening in Cosmetics & Personal Care
Wayne chats with Meredith Petillo and Claire Bing about recent activity in the cosmetics space; FDA’s PFAS report and the January 1 state compliance deadline; the agency’s guidance on inspections and other areas; the impact of rising state actions; how the agency can battle misconceptions about the cosmetics industry and… Listen ⇢
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Food Safety in the Spotlight
Wayne chats with Mason Weeda and Jessica O’Connell about FDA’s handling of the ongoing Cyclospora outbreak, other food enforcement actions and inspections, potential changes ahead to the GRAS framework, where the agency’s fight against synthetic food dyes stands, top-of-mind issues for the rest of 2026 and 2027, and much more. Listen ⇢
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FDA Legal, Regulatory & Compliance Issues, Part 3: Advertising & Promotion
In this third part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Alan Minsk and Laura LaBrie about recent actions by FDA’s Office of Prescription Drug Promotion surrounding direct-to-consumer advertising, AI’s role with OPDP enforcement and company promotion and review, and promotional areas getting the most attention in review committees recently. They also address how to navigate issues with… Listen ⇢
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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 ⇢
