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.
In this second part of our series in collaboration with Arnall Golden Grego ry LLP , Wayne chat s 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 info rmation about our podcast, visit FDAW at ch .net . Want to be a spon sor, marketing p artner, or guest, or provide feedback on the podcast ? E mail us a t info@fdawatch.net . Music by Dvir Silver from Pixabay .
In this first part of our series in collaboration with Arnall Golden Grego ry LLP , Wayne chat s with Gabriel Scannapieco, Partner at A GG and C o-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 info rmation about our podcast, visit FDAW at ch .net . Want to be a spon sor, marketing p artner, or guest, or provide feedback on the podcast ? E mail us a t info@fdawatch.net . Music by Dvir Silver from Pixabay .
Wayne chat s 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 spon sor, marketing p artner, or guest, or provide feedback on the podcast ? E mail us a t info@fdawatch.net . Music by Dvir Silver from Pixabay .
In this third and final part of our series in collaboration with White & Case and BRG , Wayne chat s with Lauren Papenhausen, P artner 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 info rmation about our podcast, visit FDAW at ch .net . Want to be a spon sor, marketing p artner, or guest, or provide feedback on the podcast ? E mail us a t info@fdawatch.net . Music by Dvir Silver from Pixabay .
In this second part of our series in collaboration with White & Case and BRG , Wayne chat s with Bethany Hills, P artner 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 info rmation about our podcast, visit FDAW at ch .net . Want to be a spon sor, marketing p artner, or guest, or provide feedback on the podcast ? E mail us a t info@fdawatch.net . Music by Dvir Silver from Pixabay .
In this first part of our series in collaboration with White & Case and BRG , Wayne chat s with Bethany Hills, P artner 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 info rmation about our podcast, visit FDAW at ch .net . Want to be a spon sor, marketing p artner, or guest, or provide feedback on the podcast ? E mail us a t info@fdawatch.net . Music by Dvir Silver from Pixabay .
In the final part of our series in collaboration with Skadden , Wayne chat s 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 info rmation about our podcast, visit FDAW at ch .net . Want to be a spon sor, marketing p artner, or guest, or provide feedback on the podcast ? E mail us a t info@fdawatch.net . Music by Dvir Silver from Pixabay .
Wayne chat s 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 info rmation about our podcast, visit FDAW at ch .net . Want to be a spon sor, marketing p artner, or guest, or provide feedback on the podcast ? E mail us a t info@fdawatch.net . Music by Dvir Silver from Pixabay .
Wayne chat s with Jessica O'Connell , P artner at Covington and Co-Chair of the firm's Food, Drug, and Device Practice Group; and Rebecca Dandeker, Partner in the Food and Drug P ractice 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 the se links , subscribe , or find out more info rmation about our podcast, visit FDAW at ch .net . Want to be a spon sor, marketing p artner, or guest, or provide feedback on the podcast ? E mail us a t info@fdawatch.net . Music by Dvir Silver from Pixabay .
Wayne chat s 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 potentia l 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 the se links , subscribe , or find out more info rmation about our podcast, visit FDAW at ch .net . Want to be a spon sor, marketing p artner, or guest, or provide feedback on the podcast ? E mail us a t info@fdawatch.net. Music by Dvir Silver from Pixabay .
Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies LLC, and Stuart Pape, Senior Partner and Food and Drug Chair at Polsinelli. Together, they discuss the resignation of Dr. Marty Makary as FDA Commissioner, the installment of former Deputy Commissioner of Human Foods Kyle Diamantas as Acting Head of the agency, qualifications of FDA Commissioner, potential timing of a new official Commissioner, and much more. This episode and all bonus episodes do not include the usual Headlines and Resources Links segments. Want to be a spon sor, marketing p artner, or guest, or provide feedback on the podcast ? E mail us a t info@fdawatch.net . Music by Dvir Silver from Pixabay .
Wayne chat s with Mark DuVal, CEO of DuVal & Associate; Bryan Feldhaus, President of DuVal & Associates; and Chris Lyle, Vice President of Evidence Strategy at DuVal & Associates . You'll hear their thoughts on what's happening right now at FDA and in the medical device industry; whether companies should engage FDA early in the pre-submission process or make their case in the actual submission; common breakdowns in the submission process ; the importance of real-world evidence and where companies can still fall short; holding FDA to a consistent standard after initial feedback; and much more. In our headlines segment, Wayne highlights these major developments: Pharma: FDA reports progress after first year of roadmap to reduce animal testing in drug development Devices: CDRH issues letter to combination product manufacturers with information on potential nitrosamine impurities Food: FDA issues warning letters to food companies following serious violations Cosmetics: FDA releases Grand Rounds presentation recording featuring experts from Office of Cosmetics and Colors In our Resource Links segment, we list key documents in our four core areas. To view the se links , subscribe , or find out more info rmation about our podcast, visit FDAW at ch .net . Want to be a spon sor, marketing p artner, or guest, or provide feedback on the podcast ? E mail us a t info@fdawatch.net . Music by Dvir Silver from Pixabay .
Wayne chat s with Geoffrey Levitt, Head of Global Regulatory Law at argenx , and Frank Sasinowski , Director at Hyman, Phelps & McNamara . You'll hear their thoughts on the recently introduced p lausible m echanism f ramework for individualized therapies in ultra-rare diseases ; where FDA is making meaningful progress for rare-disease sponsors and where gaps persist ; the agency's willingness to exercise regulatory flexibility in rare diseases ; recent experiences in dealing with FDA on orphan drugs ; how the agency has fared in translating concepts such as historical data, real-world evidence, and patient engagement into review decisions; and much more . In our headlines segment, Wayne highlights these major developments: Pharma: FDA - backed proposals aim to entice pharma companies to test and produce drugs domestically Devices: FDA launches READI-Home Innovation Challenge Food: FDA seeking public input on potential market name change for 18 species of rockfish Cosmetics: P rocessors must complete first biennial FDA facility registration renewals by July 1, as required under MoCRA In our Resource Links segment, we list key documents in our four core areas. To view the se links , subscribe , or find out more info rmation about our podcast, visit FDAW at ch .net . Order the Food & Drug Law Institute's A Practical Guide to FDA's Food and Drug Law and Regulation, Eighth Edition . Want to be a spon sor, marketing p artner, or guest, or provide feedback on the podcast ? E mail us a t info@fdawatch.net . Music by Dvir Silver from Pixabay .
In the third part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Milli Hansen, Partner in Skadden's Mass Torts, Insurance and Consumer Litigation Group; Daniel Luks, Partner in Skadden's Mergers & Acquisitions Practice; and Douglas Stearn, Principal at Canal Row Advisors. Together, they discuss the latest developments in food regulation at FDA and at the state level; how companies may want to prepare for potential FDA and state enforcement actions and policy shifts in the coming year; how the regulatory environment impacts litigation; how regulatory uncertainty and litigation affect M&A deals; how companies can navigate the evolving food environment; 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.
In the second part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Bill Ridgway, Co-Head of Skadden's Global Cybersecurity and Data Privacy Practice; Michelle Gasaway, Partner in Skadden's Capital Markets Practice; and Carolyn Bruguera, Vice President and General Counsel at the Medical Device Manufacturers Association. Together, they discuss considerations for companies who manufacture, design and/or develop medical devices, including general wellness devices, regarding whether to submit a 510(k); how to proactively prepare for and anticipate complex regulatory, diligence and disclosure issues in preparing for a public offering, private financing or other transaction; the intersection of FDA regulation, privacy law, and cybersecurity in AI for wellness and medical devices; cybersecurity False Claims Act risk for technology and life sciences companies; privacy considerations for those who collect information from wellness and medical devices; what companies in the space should watch for; 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.
In this first part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Raquel Fox, Head of Skadden's U.S. ESG Practice and Co-Head of the firm's SEC Reporting and Compliance Practice; Kendall Ickes, Associate in Skadden's Intellectual Property and Technology Practice; and Tess Cameron, Managing Director on the Venture Team at RA Capital Management. Together, they discuss helping pharmaceutical and biotech industry clients navigate the uncertain regulatory environment; how FDA is expanding its scope of responsibility; staffing and policy changes at FDA and how they impact the review process; considerations from an SEC disclosure perspective for how companies talk about their product development; protections and assurances buyers may be looking for in the deal context; 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 www.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.
In this fourth and final part of our series in collaboration with Covington, Wayne chats with Kristin Davenport, Christina Kuhn, and Olivia Dworkin, Attorneys at Covington; and Jackie Haydock, Chief Healthcare Compliance Officer and Associate General Counsel at Meta. Together, they discuss the evolving landscape of digital health worldwide; FDA's revised guidance on general wellness as it relates to digital health and consumerism; considerations for consumer product companies as they enter the regulated health space; regulatory challenges with multifunction products; what's on the horizon for FDA and industry in digital health and AI; 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 .
In this third part of our series in collaboration with Covington, Wayne chats with Pam Forrest, Partner and Co-Chair of Covington's Medical Device Industry Group; Michael Granston, Partner and Chair of Covington's False Claims Act Investigations and Litigation practice; and Krysten Rosen Moller, Partner in Covington's Life Sciences Enforcement practice. Together, they discuss the government's current use of the False Claims Act to pursue healthcare fraud; issues that could lead to potential False Claims Act liability for medical device manufacturers; preventive actions device manufacturers can take to reduce enforcement exposure; cases challenging the constitutionality of the act's whistleblower provisions; developments in the government's ability to pursue False Claims Act liability for kickbacks; 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 .
Wayne chats with Lizzy Lawrence, Lead FDA Reporter at STAT; Derrick Gingery, Executive Editor for U.S. Regulatory and Policy Insights at The Pink Sheet; and Sarah Karlin-Smith, Research Director at Public Citizen's Access to Medicines Program and former Reporter at The Pink Sheet. Together, they offer overarching themes surrounding FDA coverage today; how access to FDA decision-makers and frontline staff has changed recently; FDA's tendency to announce policies via video announcements and press releases instead of through official guidances; how reporters decide what gets media attention; how the absence of advisory committees has created reporting challenges; stories reporters are eager to chase moving forward; and much more. 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 .
Wayne chats with Rend Al-Mondhiry, Co-Chair of the Regulatory Practice Group at Amin Wasserman Gurnani, and Will Woodlee, Managing Partner at Kleinfeld, Kaplan & Becker . You'll hear their thoughts on FDA's recent "Report on the Use of PFAS in Cosmetic Products and Associated Risks"; how FDA and Congress might work toward addressing PFAS and other "forever chemicals" moving forward; challenges associated with state versus federal oversight on cosmetic ingredients; how the implementation of MoCRA could be changing the regulatory landscape for cosmetic companies; and much more. In our headlines segment, Wayne highlights these major developments: Pharma: FDA launches PreCheck Pilot Program Devices: Two digital health and device leaders leave agency Food: FDA finalizes policy limiting "no artificial colors" claims Cosmetics: Virginia lawmakers introduce Humane and Toxin-Free Cosmetics Act 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 .
