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Recent Episodes
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Breaking Down Cosmetics Safety, Imports & MoCRA
Shelly and Wayne chat with PCPC’s Emily Manoso about the state of cosmetics regulation and safety under the new administration, cosmetic and personal care product imports, the implementation and enforcement of MoCRA, FDA’s fragrance allergen labeling rule, and much more. Listen ⇢
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AI, Medical Products & FDA, Part 3: AI in Drug & Device Commercialization
In the final part of our AI series with Arnold & Porter, Shelly and Wayne chat with Philip Desjardins, Mahnu Davar, and William Maisel about the use of AI for clinical decision support, AI’s impact on advertising and promotion, “AI washing,” FDA’s first AI-assisted scientific review pilot, and much more. Listen ⇢
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Homing in on Food Supply, Tariffs & Infant Formula
Shelly and Wayne chat with Martin Hahn and Tony Pavel about global food supply chain vulnerabilities; how U.S. tariffs on imported food products influence the availability and safety oversight of essential goods; how FDA is working with international partners to improve transparency; FDA measures to ensure a more resilient infant… Listen ⇢
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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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