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Recent Episodes
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AI, Medical Products & FDA, Part 2: AI Discovery, Design & Development
In part two of our AI series with Arnold & Porter, Shelly and Wayne chat with Howard Sklamberg, Eva Temkin, and Marko Topalovic about how AI can accelerate drug discovery and design and be used in clinical trials, how FDA could use AI to evaluate manufacturers’ data integrity operations, and… Listen ⇢
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Devices, Disruption & the Road Ahead
Shelly and Wayne chat with Dr. Daniel Schultz and Jonathan Kahan about the effect of CDRH staff reductions on medical device reviews and market authorizations, how FDA is responding to device shortages and supply interruptions, the effectiveness of the current post-market surveillance system in detecting device-related adverse events, and much… Listen ⇢
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Breaking Down Pharma in the Current Environment
Shelly and Wayne chat with Dr. Michelle McMurry-Heath and Alan Minsk about the potential effects that FDA staffing cuts may have on drug and biologics approvals; how the current environment may affect investments in drug and biotech development; how FDA can aim to include all demographics of patients in trials;… Listen ⇢
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The State of Protection, Innovation & Communication at FDA
Shelly and Wayne chat with Ron Bartek and Ralph Hall about the overall situation at FDA right now; its impact on agency activities and innovation; what areas will be most impacted; what policy changes might be coming; and much more. Listen ⇢
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AI, Medical Products & FDA, Part 1: AI Overview in Life Sciences
In this first part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with guests about Arnold & Porter’s recent survey on AI adoption in life sciences; problems, challenges, and successes in AI adoption in drug and medical device development; where FDA may be hampered in… Listen ⇢
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Examining the Cosmetics Compliance and Enforcement Landscape
Shelly and Wayne chat with Justin Prochnow, Partner in the Denver office of Greenberg Traurig, about what FDA could be prioritizing in cosmetics under new FDA Commissioner Dr. Marty Makary; compliance and enforcement obstacles with MoCRA implementation; challenges companies are facing from class-action attorneys; the intersection of cosmetics and environmental… Listen ⇢
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A New Era of Unprecedented Change
Shelly and Wayne chat with Nancy Myers, CEO of Catalyst Healthcare Consulting, and Stuart Pape, Senior Partner and Chair of the FDA Practice at Polsinelli, about what companies should be doing now amid changes at FDA, including the recent confirmation of Dr. Marty Makary as the agency’s new commissioner; the… Listen ⇢
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The Latest in FDA’s Focus on Foods
Shelly and Wayne chat with Dr. Susan Mayne and Dr. Peter Lurie about why it took FDA so long to ban Red Dye No. 3, the agency’s “healthy” claim final rule, where FDA stands with reducing sodium in human foods, the push to eliminate the self-affirmed GRAS pathway, and much… Listen ⇢
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What’s Happening in Software and Device Regulation
Shelly and Wayne chat with Jennifer Newberger and Michael Gaba about anticipated changes in the review and approval of PMAs, 510ks, and de novo applications; clinical trial requirements for SaMD; and much more. Listen ⇢
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