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Recent Episodes
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The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals
In this third part of our series with Analysis Group, Wayne chats with Dr. Maral DerSarkissian, Dr. Mark Robbins, and Bethany Hills about expedited FDA drug development and review pathways; accelerated approval and its value to sponsors and investors; surrogate endpoints and their role in accelerated approval; the Food and… Listen ⇢
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The Rise of Real-World Evidence in Regulatory Strategy, Part 2: RWE in Medical Devices
In this second part of our series with Analysis Group, Wayne chats with Dr. Mary Beth Ritchey and Cori Maegley about how real-world evidence applies to medical devices; where RWE for medical devices comes from; what CDRH can learn from CDER and CBER about using RWE and vice versa; examples… Listen ⇢
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An Evolving Direction for Drug Oversight
Wayne chats with Brian Malkin about potential FDA leadership under Heidi Overton, early priorities for drug and biologics companies, implications for drug pricing, AI in drug development, new approach methodologies and the shift away from animal testing, sponsor use of NAMs in place of traditional animal studies, skinny labeling, and… Listen ⇢
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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 ⇢
