Keeping Up with Medical Device Manufacturing and Digital Health
FDA Watch
Wayne chats with Cathy Burgess, Partner and Head of the FDA Compliance and Enforcement Team and FDA Practice at Alston & Bird, and Michael Gaba, Food and Drug Vice Chair at Polsinelli. You’ll hear their thoughts on what’s happening these days at CDRH; key issues for medical device manufacturers, such as QSMR implementation and enhanced cybersecurity requirements; the evolution of digital health and its impact on clinical decision support technologies and wellness products; what could be next for user fee authorization; potential risks...
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An Extensive Breakdown of the Pharmaceutical and Biologics Landscape
FDA Watch
Wayne chats with Daniel Kracov, Partner and Chair of the Life Sciences Industry Group at Arnold & Porter, and Dr. Gayatri Rao, Director at Hyman, Phelps & McNamara. You’ll hear their thoughts on 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. In our headlines...
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FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade
FDA Watch
In this second part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Luis Arandia Jr., Partner and Co-chair of International Trade at AGG, and Allison Raley, Partner in AGG’s Corporate & Finance practice and Chair of the firm’s International Compliance & Risk team. Together, they discuss how pharmaceutical and biologics companies should rethink global supply chains in light of the Section 232 tariffs affecting patented pharmaceutical products; common customs and trade compliance...
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FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement
FDA Watch
In this first part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Gabriel Scannapieco, Partner at AGG and Co-chair of the firm’s Life Sciences industry team. Together, they discuss 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 mean for FDA enforcement; other products drawing attention from FDA and DOJ; recent FDA enforcement actions; what companies...
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Midyear Review: 2026 So Far & a Look Forward
FDA Watch
Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies LLC, and Dr. Susan Mayne, Adjunct Professor at the Yale School of Public Health and former Director of FDA’s Center for Food Safety and Applied Nutrition. Together, they dive into 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. This episode and all bonus episodes do not include the usual Headlines and Resources Links segments. Want to be a sponsor, marketing...
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From Price Strategy to Enforcement Risk
FDA Watch
In this third and final part of our series in collaboration with White & Case and BRG, Wayne chats with Lauren Papenhausen, Partner at White & Case’s Boston office, and Edward Buthusiem, Managing Director at BRG. Together, they discuss 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 pricing...
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When Pricing Pressure Reaches the FDA File: Practical FDA Realities
FDA Watch
In this second part of our series in collaboration with White & Case and BRG, Wayne chats with Bethany Hills, Partner at White & Case, and Dan Troy, Managing Director at BRG. Together, they discuss 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 flashpoints in pricing issues with FDA; lawful product differentiation versus differentiation that may later be portrayed as regulatory...
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Governmental Policy Levers: Navigating Drug Pricing Across Agencies and Congress
FDA Watch
In this first part of our series in collaboration with White & Case and BRG, Wayne chats with Bethany Hills, Partner at White & Case’s New York office; Rahul Rao, Partner in White & Case’s Washington, D.C., office; and John Barkett, Managing Director in BRG’s Healthcare Transactions and Strategy practice. Together, they discuss FDA and product-strategy decisions that actually determine future pricing power developments; how certain factors shape market structure in ways that could attract anti-trust...
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FDA’s Regulatory Revisions: Business & Legal Impact on Industry, Part 4 – Consumer Products
FDA Watch
In the final part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden’s Regulatory Practice; Amy Van Gelder, Head of Skadden’s Chicago Litigation Practice; Brett Fleisher, M&A Partner at Skadden; and Katherine Armstrong, Deputy Director for the National Advertising Division of BBB National Programs. Together, they discuss how the regulatory approach to consumer products is evolving; how companies should respond to a broader and increasingly varied policy...
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Breaking Down FDA’s Proposed FY27 Budget
FDA Watch
Wayne chats with Dr. Cartier Esham, CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA. Together, they discuss FDA’s proposed fiscal year 2027 budget, examine how it compares with past agency budgets, break down allocations and funding for multiple areas, look at Congress’ role in budget review and approval, and much more. Learn more about the Alliance for a Stronger FDA at . This episode and all bonus episodes do not include the usual Headlines and Resources Links segments. To subscribe or...
info_outlineIn our first episode, Shelly and Wayne chat with Nikki Reeves, Partner in the FDA & Life Sciences practice at King & Spalding, and Brian Malkin, Associate General Counsel for Regulatory Law at Teva Pharmaceuticals. You’ll hear their thoughts on the top priorities in pharmaceutical regulation for the next FDA commissioner and their insights on AI policy, patient voices, and other front-burner issues.
In our headlines segment, Shelly and Wayne delve into these major developments:
Pharma: More than 200,000 Prescriptions for Wegovy Filled
Devices: FDA Announces Communication Pilot on Recalls
Food: Fruits & Vegetables: Are They Really Safe?
Cosmetics: FDA Issue Final Rule on Color Additive Certification Fees
In our Resource Links segment, we listed key documents in our fore core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.
Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@FDAWatch.net.
Music by Dvir Silver from Pixabay.