Podcast
FDA Watch
Hosted by FDA Watch · EN
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.
36episodes
Episodes
Newest firstAll episodes
FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade
2w ago00:39:30Tap to summarizeIn 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 feedback on the podcast? Email us at info@fdawatch.net. Music by Dvir Silver from Pixabay.
Transcribe →FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement
3w ago00:41:03Tap to summarizeIn 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. Music by Dvir Silver from Pixabay.
Transcribe →Midyear Review: 2026 So Far & a Look Forward
Jul 1300:50:01Tap to summarizeWayne 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.
Transcribe →From Price Strategy to Enforcement Risk
Jul 600:44:38Tap to summarizeIn 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? Email us at info@fdawatch.net. Music by Dvir Silver from Pixabay.
Transcribe →When Pricing Pressure Reaches the FDA File: Practical FDA Realities
Jun 1500:42:04Tap to summarizeIn 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 info@fdawatch.net. Music by Dvir Silver from Pixabay.
Transcribe →Governmental Policy Levers: Navigating Drug Pricing Across Agencies and Congress
Jun 800:53:52Tap to summarizeIn 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 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.
Transcribe →FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 4 – Consumer Products
Jun 100:40:37Tap to summarizeIn 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? Email us at info@fdawatch.net. Music by Dvir Silver from Pixabay.
Transcribe →Breaking Down FDA's Proposed FY27 Budget
May 2800:30:27Tap to summarizeWayne 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 Dvir Silver from Pixabay.
Transcribe →What's Next for Cosmetics and Personal Care Products?
May 2600:47:12Tap to summarizeWayne chats with Jessica O'Connell, Partner at Covington and Co-Chair of the firm's Food, Drug, and Device Practice Group; and Rebecca Dandeker, Partner in the Food and Drug Practice at Wiley Rein. You'll hear their thoughts on the recent leadership changes at FDA; unanswered questions for the cosmetics industry as they move into long-term compliance with FDA's MoCRA requirements; the agency's draft guidance on its mandatory recall authority for cosmetics; how companies should be thinking risk management amid an influx of state regulatory movement; challenges balancing science, enforcement, and industry feasibility in cosmetics; the need for greater compliance and legal functions at cosmetics companies; where cosmetics and MoCRA could be headed next; and much more. In our headlines segment, Wayne highlights these major developments: FDA announces major expansion of internal AI capabilities, including rollout of "Elsa 4.0" Pharma: FDA seeks input on new efforts to expand drug repurposing Devices: FDA adds neurosurgical patties to medical device shortage list, warns supply disruptions could impact patient care Food: FDA launches "Know Your Nutrition" campaign during National Women's Health Week Cosmetics: PCPC joins coalition filing complaint challenging California's SB 343 In our Resource Links segment, we list key documents in our four 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.
Transcribe →A Fresh Look at the State of Human Foods
May 1800:48:03Tap to summarizeWayne chats with Brian Sylvester, Partner in Morrison Foerster's FDA and Healthcare Regulatory and Compliance Group, and Scott Faber, Senior Vice President of Government Affairs for the Environmental Working Group. You'll hear their thoughts on the recent appointment of former Deputy Commissioner of Human Foods Kyle Diamantas to Acting Head of FDA after the resignation of former Commissioner Dr. Marty Makary; the direction and drivers of food regulation; the phase-out of synthetic food dyes amid growing state-level action; where FDA's interest in overhauling GRAS stands; the potential formal definition of "ultraprocessed" foods and potential labeling and nutrition implications; the balance between precautionary regulation and evidence-based flexibility for industry; how AI is changing the regulatory landscape amid FDA's rollout of Elsa; and much more. In our headlines segment, Wayne highlights these major developments: Dr. Marty Makary resigns as FDA Commissioner, Human Foods Deputy Commissioner Kyle Diamantas in as Acting Head FDA to pilot "one-day inspectional assessments" Pharma: FDA issues final guidance on the collection of pregnancy safety data for drugs and biologics after approval Devices: FDA issues recall notice involving heart devices after reports of device malfunctions that could interrupt therapy delivery Food: FDA announces results from examination on chemical contaminants in infant formula Cosmetics: PCPC issues statement calling on administration to take more targeted approach in Section 301 investigation into excess manufacturing capacity In our Resource Links segment, we list key documents in our four 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.
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