Free Daily Podcast Summary
FDA Watch: Daily Summaries Delivered
by FDA Watch
FDA Watch is a twice-monthly, national podcast that provides an independent, non-partisan forum for discussing and understanding the latest developments, trends, and issues involving FDA. The podcast focuses on four core areas: pharmaceuticals and biologics; medical devices and diagnostics; food and dietary supplements; and cosmetics and personal care products, as well as on the overall direction of FDA regulation. The podcast also will have bonus episodes to cover breaking news. Podcast guests analyze FDA regulations, guidances, and policy developments and engage in insightful and revealing conversations with host Wayne Pines, former FDA associate commissioner and author/editor of 16 books about FDA. Subscribers to the podcast include regulatory affairs specialists, food and drug attorneys, policymakers, government officials, strategic planners, and IT and cybersecurity professionals.
Latest Episodes
The most recent episodes — sign up to get AI-powered summaries of each one.
- 2 days ago39 min
FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade
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 issues with imported FDA-regulated goods; legal risk-mapping to avoid detentions, refusals, and unexpected duty exposure; potential tariff actions impacting medical devices; how shifting U.S. trade policies are changing global supply chains for pharmaceuticals, biologics, and medical devices; the impact of heightened enforcement on forced labor in global supply chains; how industry should manage sanctions and export control exposure; and much more. This episode and the rest of our series do not include the usual Headlines and Resources Links segments. To subscribe or find out more information about our podcast, visit FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feed
- 1 weeks ago41 min
FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement
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 should do now and what should they watch for in the second half of the year related to enforcement; and much more. This episode and the rest of our series do not include the usual Headlines and Resources Links segments. To 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<span class= "TextRun Underlined SCXW39729665 BCX0" lang="EN-US" xml:lang= "EN-U
- 2 weeks ago50 min
Midyear Review: 2026 So Far and a Look Forward
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 partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net. Music by Dvir Silver from Pixabay.
- 3 weeks ago44 min
From Price Strategy to Enforcement Risk
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 compliance and internal controls; emerging enforcement risks from state-level drug pricing regulation; and much more. This episode and the rest of our series do not include the usual Headlines and Resources Links segments. To 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? E<span class= "NormalTextRun SCXW
- Jun 15, 202642 min
When Pricing Pressure Reaches the FDA File: Practical FDA Realities
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 gaming; why CMC issues, manufacturing resilience, and shortage risk become more consequential amid pricing pressure; documentation surrounding regulatory and product-presentation decisions that could be second-guessed through a pricing lens; and much more. This episode and the rest of our series do not include the usual Headlines and Resources Links segments. To 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 <span class="Norma
- Jun 8, 202653 min
Governmental Policy Levers: Navigating Drug Pricing Across Agencies and Congress
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 scrutiny; the line between lawful regulatory strategy and conduct that regulators or plaintiffs may characterize as competition-distorting; how management teams should think about government policy and product strategy differently amid intense price pressure; recurring fact patterns where companies unintentionally create anti-trust or stroke-of-the-pen risk; how recent political efforts around drug pricing may be tied to regulatory strategies from manufacturers; how competition authorities and deal-makers now assess FDA-derived barriers to entry in pharma and biotech; "pricing power risk" at the development stage; developments in DTC advertising; and much more. This episode and the rest of our series do not include the usual Headlines and Resources Links segments. To subscribe or find out more information about our podcast, visit <span class= "NormalTextRun SCXW1589
- Jun 1, 202640 min
FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 4 – Consumer Products
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 environment with multiple regulators; what's happening at FDA with MoCRA implementation; litigation trends across the consumer products sector; how consumer products companies are navigating a more active plaintiffs' bar; issues that are becoming more important in deal-making diligence and transaction structuring; significant risk or opportunity areas over the next year or so; and much more. This episode and the rest of our series do not include the usual Headlines and Resources Links segments. To 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<sp
- May 28, 202630 min
Breaking Down FDA's Proposed FY27 Budget
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 www.strengthenfda.org. This episode and all bonus episodes do not include the usual Headlines and Resources Links segments. To 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 <a class=
About FDA Watch
FDA Watch is a twice-monthly, national podcast that provides an independent, non-partisan forum for discussing and understanding the latest developments, trends, and issues involving FDA. The podcast focuses on four core areas: pharmaceuticals and biologics; medical devices and diagnostics; food and dietary supplements; and cosmetics and personal care products, as well as on the overall direction of FDA regulation. The podcast also will have bonus episodes to cover breaking news. Podcast guests analyze FDA regulations, guidances, and policy developments and engage in insightful and revealing conversations with host Wayne Pines, former FDA associate commissioner and author/editor of 16 books about FDA. Subscribers to the podcast include regulatory affairs specialists, food and drug attorneys, policymakers, government officials, strategic planners, and IT and cybersecurity professionals.
Customized Recaps
AI-powered recaps with compact key takeaways, quotes, and insights.
Straight to Your Inbox
Get key takeaways from FDA Watch in a 5-minute read.
Save Hours Every Week
Stay current on your favorite podcasts without falling behind.
Frequently Asked Questions
What is Podzilla's FDA Watch daily summary?
It's a free AI-powered email that summarizes new episodes of FDA Watch as soon as they're published. You get the key takeaways, notable quotes, and links & mentions — all in a quick read.
How does the FDA Watch podcast summary work?
When a new episode drops, our AI transcribes and analyzes it, then generates a personalized summary tailored to your interests and profession. It's delivered to your inbox every morning.
Is this an official FDA Watch product?
No. Podzilla is an independent service that summarizes publicly available podcast content. We're not affiliated with or endorsed by FDA Watch.
Can I get summaries of other podcasts too?
Absolutely! The free plan covers up to 3 podcasts. Upgrade to Pro for 15, or Premium for 50. Browse our full catalog at /podcasts.
How often does FDA Watch release new episodes?
FDA Watch publishes weekly. Our AI generates a summary within hours of each new episode.
What topics does FDA Watch cover?
FDA Watch covers topics including News, Government, Commentary. Our AI identifies the specific themes in each episode and highlights what matters most to you.
Start getting FDA Watch summaries tomorrow morning.
Free forever for up to 3 podcasts. No credit card required.
Free forever for up to 3 podcasts. No credit card required.