FDA Watch
- Episódios
- 74
- Publicação
- semanal
- Último episódio
- 2 nov 2026
Sobre o podcast
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.
Episódios 74
The Rise of Real-World Evidence in Regulatory Strategy, Part 4: RWE in Postmarketing Studies
In this fourth part of our series in collaboration with Analysis Group, Wayne chats with Dr. Marianne Cunnington, Managing Principal at Analysis Group, and Dr. Robert Reynolds, Vice President and Head of …
Notas do episódio
In this fourth part of our series in collaboration with Analysis Group, Wayne chats with Dr. Marianne Cunnington, Managing Principal at Analysis Group, and Dr. Robert Reynolds, Vice President and Head of Development Sciences at GSK. Together, they discuss the evolution of postmarketing drug surveillance, the current scope of postmarketing studies, triggers for postmarketing commitments and requirements, safety and effectiveness questions best addressed after approval, studying populations excluded from clinical trials, standards for robust postmarketing evidence, real-world evidence in confirmatory studies, AI and automation in postmarketing research, transparency in study protocols and results, FDA monitoring and enforcement of postmarketing requirements, and much more.
This episode and the rest of our series do not include the usual Headlines segment.
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 [email protected].
Music by Dvir Silver from Pixabay.
What's Ahead for FDA & MedTech
Wayne chats with Philip Desjardins, Partner at Arnold & Porter; Sean Boyd, Corporate Vice President at QualityHub; and Rusty Segan, CEO of Medical & Scientific Advisors. You'll hear their takeaways from …
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Wayne chats with Philip Desjardins, Partner at Arnold & Porter; Sean Boyd, Corporate Vice President at QualityHub; and Rusty Segan, CEO of Medical & Scientific Advisors. You'll hear their takeaways from AdvaMed's MedTech Conference and emerging FDA issues, plus their thoughts on CDRH priorities under Dr. Michelle Tarver and the evolution of risk-based device regulation; MDUFA reauthorization and potential device policy changes; QMSR implementation and FDA compliance and enforcement expectations; FDA oversight of AI-enabled medical devices, including PCCPs, adaptive AI, and postmarket monitoring; the RAPID pathway and alignment of FDA authorization with Medicare coverage and reimbursement; and much more
In our headlines segment, Wayne highlights these major developments:
Pharma: FDA launches Rare Disease Framework Initiative to streamline drug development while allowing flexibility
Pharma: FDA finalizes guidance for software and apps used alongside prescription drugs
Devices: Medtech industry outlines top policy priorities ahead of MDUFA VI
Food: FDA finalizes guidance on new dietary ingredient notification requirements
Cosmetics: FDA flags misleading social media promotion of Evolus' Jeuveau
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 [email protected].
Music by Dvir Silver from Pixabay.
FDA Legal, Regulatory & Compliance Issues, Part 4: Mergers & Acquisitions
In this fourth and final part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-chair of the Life Sciences industry …
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In this fourth and final part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-chair of the Life Sciences industry team at AGG; and Brian Teras, Partner in the Corporate & Securities practice at AGG. Together, they discuss current mergers and acquisitions trends and issues for FDA-regulated companies, recent shifts in the M&A environment, the FDA administration's regulatory approach and its effects on corporate transactions, the FDA Transparency Roadmap and its implications for M&A, common mistakes by buyers and sellers when evaluating deals, emerging FDA regulatory developments that could affect M&A activity, 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 [email protected].
Music by Dvir Silver from Pixabay.
The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals
In this third part of our series in collaboration with Analysis Group, Wayne chats with Dr. Maral DerSarkissian, Managing Principal at Analysis Group; Dr. Mark Robbins, President and CEO of Kodiak Strategic …
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In this third part of our series in collaboration with Analysis Group, Wayne chats with Dr. Maral DerSarkissian, Managing Principal at Analysis Group; Dr. Mark Robbins, President and CEO of Kodiak Strategic Consultants; and Bethany Hills, Regulatory Partner at White & Case. Together, they discuss expedited FDA drug development and review pathways; accelerated approval and its value to sponsors and investors; surrogate endpoints and their role in accelerated approval; the Food and Drug Omnibus Reform Act and FDA's expanded accelerated approval authorities; FDA's evolving current evidentiary standards for accelerated drug approvals; RWE in accelerated approval strategies; FDA expectations for RWE; limitations and controversies surrounding RWE; legal and compliance considerations for sponsors using RWE; and much more.
This episode and the rest of our series do not include the usual Headlines segment.
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 [email protected].
Music by Dvir Silver from Pixabay.
The Rise of Real-World Evidence in Regulatory Strategy, Part 2: RWE in Medical Devices
In this second part of our new series in collaboration with Analysis Group, Wayne chats with Dr. Mary Beth Ritchey, Principal of Med Tech Epi LLC, and Associate Research Professor at Rutgers University; and …
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In this second part of our new series in collaboration with Analysis Group, Wayne chats with Dr. Mary Beth Ritchey, Principal of Med Tech Epi LLC, and Associate Research Professor at Rutgers University; and Cori Maegley, Vice President of Partnerships Management at the National Evaluation System for health Technology (NEST), a Medical Device Innovation Consortium initiative. Together, they discuss how real-world evidence (RWE) applies to medical devices; where RWE for medical devices comes from; what CDRH can learn from CDER and CBER about using RWE and vice versa; examples of real-world application of real-world evidence in devices; how FDA's approach to RWE compares to other countries; how companies determine how much they rely on RWE and how CDRH is collaborating to help companies make those decisions; what makes RWE reliable enough for regulatory use and the importance of data quality; how AI plays into RWE for devices; and much more.
This episode and the rest of our series do not include the usual Headlines segment.
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 [email protected].
Music by Dvir Silver from Pixabay.
An Evolving Direction for Drug Oversight
Wayne chats with Brian Malkin, Partner at Spencer Fane. You'll hear Brian's thoughts on potential FDA leadership under Heidi Overton, early priorities for drug and biologics companies, implications for drug …
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Wayne chats with Brian Malkin, Partner at Spencer Fane. You'll hear Brian's thoughts on potential FDA leadership under Heidi Overton, early priorities for drug and biologics companies, implications for drug pricing, AI in drug development, new approach methodologies and the shift away from animal testing, sponsor use of NAMs in place of traditional animal studies, skinny labeling, and implications for generic drugmakers, overlooked and emerging FDA issues for pharma and biotech companies, and much more.
In our headlines segment, Wayne highlights these major developments:
FDA announces broad recruitment effort to expand range of people on advisory committees
Pharma: FDA launches expedited Investigational New Drug (IND) pilot program
Devices: AI and robotic surgery among FDA's top areas of focus in FY27 guidance priorities
Food: PepsiCo recalls over 122,000 cases of Gatorade after bottles were found to contain undisclosed Yellow No. 5 and/or Yellow No. 6
Cosmetics: FDA informs cosmetic product facilities and retailers that the agency does not provide certificates to verify compliance for cosmetic product facility registration
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 [email protected].
Music by Dvir Silver from Pixabay.
The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development
In this first part of our new series in collaboration with Analysis Group, Wayne chats with Dr. James Signorovitch, Managing Principal at Analysis Group; Bethany Hills, Regulatory Partner at White & Case; and …
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In this first part of our new series in collaboration with Analysis Group, Wayne chats with Dr. James Signorovitch, Managing Principal at Analysis Group; Bethany Hills, Regulatory Partner at White & Case; and Dr. Dilesh Doshi, Vice President of Global Health Economics & Outcomes Research at Acadia Pharmaceuticals. Together, they discuss FDA's ongoing commitment to rare disease drug development; defining real-world evidence (RWE) in the context of FDA and rare diseases; building representative and trustworthy patient registries; examples of RWE and registries supporting rare disease research and regulatory decision-making; making RWE a more systematic part of drug development and FDA evaluation; clinical development program reliance on RWE to support regulatory applications; the role of AI in collecting, analyzing, and applying RWE in rare disease drug development; and much more.
This episode and the rest of our series do not include the usual Headlines segment.
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 [email protected].
Music by Dvir Silver from Pixabay.
What's Actually Happening in Cosmetics & Personal Care
Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association, and Claire Bing, CEO and Founder of Confiance Cosmetic Group. You'll hear their …
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Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association, and Claire Bing, CEO and Founder of Confiance Cosmetic Group. You'll hear their thoughts on recent activity in the cosmetics space; FDA's PFAS report and the January 1 state compliance deadline; the agency's guidance on inspections and other areas; the impact of rising state actions; how the agency can battle misconceptions about the cosmetics industry and product safety; how FDA can support industry; what happened with a recent Washington state interim policy on lead; the need for clarity on fragrance allergen labeling, cosmetic GMPs, and formaldehyde releasers; and much more.
In our headlines segment, Wayne highlights these major developments:
FDA makes several official appointments
Pharma: U.K. commission issues recommendations for regulating AI in medicine
Devices: CDRH launches Rare Disease Impact Initiative
Food: Cyclospora outbreak draws attention to sharp decline in FDA oversight of imported foods
Cosmetics: From Cosmetics Business, FDA's peptide review could have significant implications for brands using peptides
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 [email protected].
Music by Dvir Silver from Pixabay.
Food Safety in the Spotlight
Wayne chats with Mason Weeda, Managing Principal at OFW Law and Chair of the firm's FDA Food Practice, and Jessica O'Connell, Partner at Covington and Co-Chair of the firm's Food, Drug, and Device Practice …
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Wayne chats with Mason Weeda, Managing Principal at OFW Law and Chair of the firm's FDA Food Practice, and Jessica O'Connell, Partner at Covington and Co-Chair of the firm's Food, Drug, and Device Practice Group. You'll hear their thoughts on FDA's handling of the ongoing Cyclospora outbreak, other food enforcement actions and inspections, potential changes ahead to the GRAS framework, where the agency's fight against synthetic food dyes stands, top-of-mind issues for the rest of 2026 and 2027, and much more.
In our headlines segment, Wayne highlights these major developments:
White House nominates Dr. Heidi Overton to be next FDA Commissioner
HHS plans to create two new FDA deputy commissioner positions in technology and drug areas
Pharma: FDA published 55 new and revised product-specific guidances surrounding generic drugs
Devices: FDA authorizes first wearable device in U.S. that continuously monitors glucose and ketone levels
Food: Cyclospora outbreak spreads to 20 states
Cosmetics: PCPC urges U.S. and Canadian officials to resolve escalating trade tensions
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 [email protected]
Music by Dvir Silver from Pixabay.
FDA Legal, Regulatory & Compliance Issues, Part 3: Advertising & Promotion
In this third part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-chair of the Life Sciences industry team at AGG …
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In this third part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-chair of the Life Sciences industry team at AGG; and Laura LaBrie, Associate in the Healthcare and Food & Drug practices at AGG. Together, they discuss recent actions by FDA's Office of Prescription Drug Promotion surrounding direct-to-consumer advertising, AI's role with OPDP enforcement and company promotion and review, and promotional areas getting the most attention in review committees recently. They also address how to navigate issues with competitor promotion, areas in advertising and promotion that could be in focus in 2027, 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 [email protected].
Music by Dvir Silver from Pixabay.
Keeping Up with Medical Device Manufacturing and Digital Health
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 …
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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 with AI in medical devices; and much more.
In our headlines segment, Wayne highlights these major developments:
Pharma: Advisory panel votes to recommend allowing compounding pharmacies to prepare six peptides
Devices: FDA selects Dexcom as first participant in TEMPO pilot
Food: FDA issues final order revoking the authorization for two food dyes
Cosmetics: Survey notes nearly 73% of daily cosmetic users believe FDA tests cosmetics for safety
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 [email protected].
Music by Dvir Silver from Pixabay.
An Extensive Breakdown of the Pharmaceutical and Biologics Landscape
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 …
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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 segment, Wayne highlights these major developments:
Acting FDA Commissioner Kyle Diamantas releases new strategic framework built around four public health priorities
Pharma: FDA makes 14 CRLs available, rejecting drug applications, despite previously pausing real-time CRL transparency initiative
Devices: FDA clears Software as a Medical Device with patient-facing LLM
Food: FDA delays publication of proposed rule to eliminate the GRAS pathway
Cosmetics: PCPC urges U.S. Trade Representative to ensure cosmetics and personal care products are prioritized in proposed U.S.-China Board of Trade
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 [email protected].
Music by Dvir Silver from Pixabay.
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 …
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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 feedback on the podcast? Email us at [email protected].
Music by Dvir Silver from Pixabay.
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 …
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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 [email protected].
Music by Dvir Silver from Pixabay.
Midyear Review: 2026 So Far & 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 …
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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 [email protected].
Music by Dvir Silver from Pixabay.
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 …
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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? Email us at [email protected].
Music by Dvir Silver from Pixabay.
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 …
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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 [email protected].
Music by Dvir Silver from Pixabay.
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 …
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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 FDAWatch.net.
Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at [email protected].
Music by Dvir Silver from Pixabay.
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 …
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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? Email us at [email protected].
Music by Dvir Silver from Pixabay.
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 …
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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 [email protected].
Music by Dvir Silver from Pixabay.
What's Next for Cosmetics and Personal Care Products?
Wayne 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 …
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Wayne 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 [email protected].
Music by Dvir Silver from Pixabay.
A Fresh Look at the State of Human Foods
Wayne 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 …
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Wayne 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 [email protected].
Music by Dvir Silver from Pixabay.
Where Does FDA Go From Here?
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 …
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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 sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at [email protected].
Music by Dvir Silver from Pixabay.
Insights on Evidence and Communication with FDA in Device Submissions
Wayne chats 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 …
Notas do episódio
Wayne chats 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 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 [email protected].
Music by Dvir Silver from Pixabay.
Cautious Optimism Surrounding Rare Diseases and Orphan Drugs
Wayne chats 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 plausible mechanism …
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Wayne chats 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 plausible mechanism framework 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: Processors 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 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 [email protected].
Music by Dvir Silver from Pixabay.
FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods
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 …
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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 [email protected].
Music by Dvir Silver from Pixabay.
FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices
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 …
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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 [email protected].
Music by Dvir Silver from Pixabay.
FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 1 – Pharmaceuticals
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 …
Notas do episódio
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 [email protected].
Music by Dvir Silver from Pixabay.
Medical Device Regulation, Compliance & Policy, Part 4: Digital Health & Consumers
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 …
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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 [email protected].
Music by Dvir Silver from Pixabay.
Medical Device Regulation, Compliance & Policy, Part 3: On False Claims
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 …
Notas do episódio
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 [email protected].
Music by Dvir Silver from Pixabay.
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