Explore every episode of the podcast FDA Watch

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 info@fdawatch.net. 

Music by Dvir Silver from Pixabay.

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 info@fdawatch.net. 

Music by Dvir Silver from Pixabay.

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 info@fdawatch.net. 

Music by Dvir Silver from Pixabay.

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 info@fdawatch.net. 

Music by Dvir Silver from Pixabay.

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 info@fdawatch.net

Music by Dvir Silver from Pixabay. 

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 info@fdawatch.net. 

Music by Dvir Silver from Pixabay.

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 info@fdawatch.net. 

Music by Dvir Silver from Pixabay. 

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 info@fdawatch.net. 

Music by Dvir Silver from Pixabay.  

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 info@fdawatch.net. 

Music by Dvir Silver from Pixabay. 

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. 

Music by Dvir Silver from Pixabay. 

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. 

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 info@fdawatch.net. 

Music by Dvir Silver from Pixabay. 

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 info@fdawatch.net. 

Music by Dvir Silver from Pixabay.

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 info@fdawatch.net. 

Music by Dvir Silver from Pixabay.

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 info@fdawatch.net.

Music by Dvir Silver from Pixabay. 

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 Dvir Silver from Pixabay. 

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 info@fdawatch.net. 

Music by Dvir Silver from Pixabay.  

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 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 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 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 info@fdawatch.net. 

Music by Dvir Silver from Pixabay.  

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.

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 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 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. 

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In this second part of our series in collaboration with Covington, Wayne chats with Sarah Cowlishaw, Partner in Covington's European Food, Drug and Device Practice; John Balzano, Partner in Covington's China Food, Drug and Device Practice; and Julia Post, Of Counsel in Covington's U.S. and China Food, Drug and Device Practices. Together, they discuss the top issues in the global device landscape; developments in the European and Chinese medical device spaces; cross-border access to and transfers of U.S. and Chinese data and biospecimens; how Europe and China are approaching digital health and AI in device regulation; what device companies doing business in the U.S., European Union and China should be watching for over the next year; 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. 

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Wayne chats with David Lennarz, President of Registrar Corp., 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. You'll hear their thoughts on the Human Foods Program's 2026 priority deliverables; how the new food pyramid/dietary guidelines may impact food and nutrition policy; the state of FDA's focus on food dyes; the latest labeling and ingredient disclosure; the direction of infant formula following recent recalls; GRAS reform and general food safety oversight; and much more.

In our headlines segment, Wayne highlights these major developments:

FDA reports efficiencies with ImportShield Program

Pharma: FDA and EMA jointly issue 10 guiding principles on AI in drug and biologics development

Devices: FDA increases scrutiny of direct-to-consumer self-collection kits by treating certain collection devices as regulated medical devices

Food: FDA's Human Foods Program released 2026 priority deliverables

Cosmetics: Cosmetics products potentially exposed to rodents and rodent activity at Minnesota distribution facility 

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. 

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In this first part of our series in collaboration with Covington, Wayne chats with Amy Leiser, Special Counsel at Covington; Scott Danzis, Partner at Covington; and Susan Van Meter, President of the American Clinical Laboratory Association (ACLA). Together, they discuss the history of laboratory developed test (LDT) regulation; ACLA engagement with FDA and Congress on potential diagnostics reform legislation; FDA's subsequent LDT regulation and ACLA's  decision to initiate litigation; current issues facing laboratories and in vitro diagnostics manufacturers; how the rise of AI is impacting diagnostics; the potential for Congress to reengage on diagnostics regulation moving forward; 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.

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Wayne chats with Mike Ryan, Executive Vice President at ELIQUENT and former FDA staffer at CDRH, and Michael Gaba, Food and Drug Vice Chair at Polsinelli. You'll hear their thoughts on where the relationship between FDA and the device industry stands right now; factors that influence how reviewers assess risk, credibility, and readiness during submission reviews; the role of the TPLC approach at CDRH; FDA's elimination of the requirement that RWE submissions include identifiable patient-level information; practical changes sponsors can make to improve regulatory outcomes, without increasing time or cost; and much more.

In our headlines segment, Wayne highlights these major developments: 

Pharma: FDA outlines new "more flexible" approach to CMC requirements for cell and gene therapies

Devices: FDA publishes two final guidance documents clarifying wearable and AI-enabled device oversight

Food: FDA Commissioner Makary chats about new food pyramid on NPR's All Things Considered

Cosmetics: U.S. Rep. Randy Weber introduces PACK 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.

Wayne chats with Rumi Young, Director of Regulatory Policy at Novo Nordisk, and Jamie Gamerman, Head of Regulatory Policy at UCB. You'll hear their thoughts on how FDA policy is developed and is evolving; how previous PDUFAs have changed the agency's policy agenda and how those commitments translate into guidance development; the most important scientific or technical inflection points driving FDA policy right now; what drives the development of new agency frameworks or programs; how companies internalize new FDA policies where disconnects may exist; FDA's efforts to balance scientific integrity with regulatory flexibility in policy development for issues such as rare diseases; and much more.

In our headlines segment, Wayne highlights these major developments: 

Pharma: FDA awards two more vouchers under Commissioner's National Priority Voucher pilot program

Pharma and Devices: FDA updates approach to incorporating RWE into drug and medical device application reviews

Food: Consumer advocate coalition urges top health officials to take action to protect infant formula safety amid ongoing Clostridium botulinum outbreak

Cosmetics: FDA finds data insufficient to determine safety of most PFAS in cosmetics

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. 

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Wayne chats with the following guests in their respective fields of expertise:

Pharma: Paul Kim, Principal, Kendall Square Policy Strategies LLC

Devices: John Sawyer, President, Realistic Quality Solutions, LLC

Food: Stuart Pape, Senior Partner and Food and Drug Chair, Polsinelli

Cosmetics: Angela Diesch, Partner and Head of the Cosmetics Industry Group at PLG (Potomac Law)

Each guest dives into the top FDA developments from 2025 in their respective areas, as well as the top developments to watch for in 2026.

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.

Wayne chats with Dr. Ritu Nalubola, Director of Life Sciences and Healthtech at Marwood Group and former FDA leader, spanning several roles over more than two decades. Together, they discuss how deregulation has been playing out at FDA; industry incentive programs, such as the Commissioner's National Priority Voucher program and PreCheck program; how agency efforts to streamline regulation could affect product safety; how tariffs and MFN impact FDA and industry; the agency's role in regulating AI and supporting AI applications; broader initiatives on health data and governance; Ritu's thoughts on where things may be headed in 2026; 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.

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In this fourth and final part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Michelle Butler, Director at HPM; Charles Raver, Associate at HPM; and Josephine Torrente, Director at HPM. Together, they discuss potential avenues to resolve a disagreement informally; how the formal dispute resolution (FDR) process works; why companies would engage in the FDR process and what constitutes a win; common misconceptions about the FDR process; what changes may be coming to the FDR process; 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 Rachel Raphael, Partner at Morgan Lewis, and Ronie Schmelz,  Partner at K&L Gates. You'll hear their thoughts on what's happening at FDA in cosmetics and personal care products; how companies should navigate ingredient concerns amid federal inaction, aggressive state laws, and stricter foreign regimes; the state of regulation surrounding labeling and advertising and promotion; what industry should be keeping an eye on heading into 2026; and much more.

In our headlines segment, Wayne delves into these major developments:

Tensions reported between FDA Commissioner Dr. Marty Makary and HHS Secretary Robert F. Kennedy Jr.

Pharma: From the Guardian, finding CDER Director replacement left FDA in state of "turmoil" and "tensions"

Devices: From the Economic Times, European medical device manufacturers feeling U.S. tariff squeeze

Food: RFK Jr. calls for greater food allergy research at Food Allergy Fund Leadership Forum

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.

Wayne chats with Sarah Sorscher, Director of Regulatory Affairs at the Center for Science in the Public Interest, and Sarah Gallo, Senior Vice President of Product Policy and Federal Affairs at the Consumer Brands Association. You'll hear their thoughts on the current state of foods at FDA, concerns related to the agency's budget, impacts of the government shutdown on FDA and the Human Foods program, how federal regulation might affect state regulation, changes to the GRAS process and post-market review, how industry is adapting to evolving guidance on ultraprocessed foods, and much more.

Read Sarah Sorscher's statement and article on the Marshall bill.

In our headlines segment, Wayne delves into these major developments: 

FDA returns to work following historic government shutdown

Pharma:

• Richard Pazdur named new CDER director
• FDA announces next round of priority review vouchers

Devices: MD+DI analysis shows slowdown in device regulatory review process

Food: From ProPublica, FDA foreign food safety inspections hit historic low

Cosmetics:  Neutrogena recalls potentially contaminated makeup wipes

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.

In this third part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Sara Koblitz, Director at HPM; Kurt Karst, Director at HPM; and Karin Hessler, General Counsel at the Association for Accessible Medicines. Together, they discuss the biggest hurdles that the generic industry needs to overcome in today's regulatory environment; the effect of pressure on industry to continue lowering drug prices; how the Hatch-Waxman Act has played out over the past 40 years; how the act can be used to address drug shortages; incentives for companies to develop follow-on products to avoid shortages; how tariffs are impacting generic drug manufacturing overseas; 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 second part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with John Claud, Counsel at HPM; Peter Dickos, Counsel at HPM; and Andrew Hull, Director at HPM. Together, they discuss the current enforcement environment at FDA; foreign inspections of pharmaceuticals and how companies should respond to 483s; False Claims Act theories for liability, specifically in areas such as cybersecurity, tariffs, DEI compliance, and CID/subpoena responses; key considerations in determining whether to enter into a consent decree with the agency; trends in enforcement discretion; 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 Sandra Cohen Kalter, member of the Strategic Advisory Group for iTolerance and a retired legal regulatory attorney from industry, and Steve Silverman, President of the consultancy The Silverman Group. You'll hear their thoughts on how CDRH has been affected over the past year, whether the center has the resources and cross-agency collaboration it needs to fulfill its regulatory mandate, FDA's capacity to support innovation amid review pressure and staffing cuts, how companies can find reliable up-to-date regulatory information that's not available through FDA communications avenues, FDA's ability to monitor safety and performance throughout a device's life cycle, and much more.

In our headlines segment, Wayne delves into these major developments: 

Pharma: From STAT, biotech leaders say FDA uncertainty threatens drug development

Devices: FDA alerts healthcare providers, patients, and caregivers to complications with radiofrequency microneedling devices

Food: FDA remains busy with food recalls, this time for cinnamon and eggs

Cosmetics: Personal Care Insights spotlights growing wave in cosmetics: human-derived ingredients

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.

Wayne chats with Cartier Esham, CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA, and Elizabeth Jungman, Partner at Hogan Lovells in the firm's Pharmaceuticals and Biotechnology practice. You'll hear their thoughts on FDA's maintenance of its drug review process amid staffing cuts; the agency's new PreCheck program and how it may proceed; FDA's evolving stance on confirmatory evidence and accelerated approvals and how they could reshape how companies approach clinical trial designs or risk disclosures; agency budgets; ramped-up AI use at the agency and in industry; and much more.

In our headlines segment, Wayne delves into these major developments:

Pharma: Former CBER Director Dr. Peter Marks joins Eli Lilly

Devices: FDA seeks public input on how best to measure and evaluate AI-enabled medical devices

Food: FDA continues to investigate Listeria and Salmonella outbreaks across U.S.

Cosmetics: Jury awards $966 million to family of deceased California woman, finding that Johnson & Johnson's talc-based baby powder contributed to mesothelioma

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.

In this first part of our series in collaboration with Hyman, Phelps & McNamara, P.C. (HPM), Wayne chats with James Valentine, Director at HPM; Frank Sasinowski, Director at HPM; Louise Himmelstrup, Vice President of Regulatory Affairs at Zevra Therapeutics; and Kate McCurdy, Co-Founder and Board Chair of the Barth Syndrome Foundation. Together, they discuss the current status of orphan drug approvals at FDA; why confirmatory evidence is particularly important in rare disease development programs, how confirmatory evidence is being and has been applied, and how confirmatory evidence is evolving; new ways in which sponsors and FDA are engaging with accelerated approvals through greater use of intermediate clinical endpoints; ultra-rare disease pathways, including FDA's new Rare Disease Evidence Principles, and why diseases like Barth syndrome and Niemann-Pick disease type C face such challenges with the agency; 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 Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association. You'll hear her thoughts on recent FDA warning letters to sunscreen brands; the mention of sunscreens in the new MAHA report; "foodification" risks in beauty and the personal care products space; how companies can prepare for potentially increased agency focus on non-traditional product formats; OMUFA, how it could impact innovation and competition in the OTC space, and its effect on small businesses; and much more.

Check out IBA's Cosmetics Convergence Fall 2025: Indie Beauty Compliance Edition, a two-day virtual conference happening Nov. 12–13, for further updates and practical guidance on beauty and personal care industry compliance. FDA Watch listeners get 10% off registration with discount code IBAFDA10.

In our headlines segment, Wayne delves into these major developments:

HHS issues new MAHA report

President Trump signs executive order regarding DTC advertising; FDA Commissioner Makary sends letters to pharma companies saying new rules and stricter enforcement coming

Pharma and Devices: OMB releases Spring 2025 regulatory agenda

Food: FDA launches new Nationalized Entry Review program

Cosmetics: EU bans gel nail polishes that continue to be sold in U.S.

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.   

Wayne chats with Claudia Lewis, Co-Chair of the FDA Group at Venable, and Ricardo Carvajal, Director at Hyman, Phelps & McNamara. You'll hear their thoughts on FDA's focus and direction on ultraprocessed foods; GRAS regulation and former FDA Commissioner Dr. David Kessler's citizen petition; potential agency updates to food nutrition labeling; inspections and food safety; FDA's use of AI in food decision-making; and much more.

In our headlines segment, Wayne delves into these major developments:

Pharma: Substantial publicity surrounds firing of CDC Director Susan Monarez

Devices: FDA launces Regulatory Accelerator for digital health devices

Food: HHS and Secretary Kennedy to issue second MAHA report

Cosmetics: FDA issues warning letters to sunscreen companies making mousse products

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.

Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies and former head of FDA and federal government strategies practices at a leading law firm for 20 years. Together, they discuss major legal issues and concerns with what the agency is aiming to accomplish; priorities for CDER Director Dr. George Tidmarsh and CBER Director Dr. Vinay Prasad; the direction of CDER and CBER on orphan drugs, rare diseases, and vaccines; reviews under the Commissioner's National Priority Voucher Program; 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 Neil O'Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani, and Bobbi Druyor-Sanchez, Partner with NDA Partners. You'll hear their thoughts on what's happening at CDRH with warning letters and inspections for medical devices, AI-enabled medical devices and the ongoing situation with Whoop, and much more.

In our headlines segment, Wayne delves into these major developments:

FDA releases new staff manual on "Gold Standard Science" policy

Pharma: U.S. District Court upholds FDA authority to regulate homeopathic drugs as "new drugs" under the FD&C Act

Pharma: HHS brings back task force on childhood vaccines

Devices: FDA declares PFAS in medical devices safe

Food: FDA issues warning about imported cookware that may leach lead into food

Cosmetics: In recent webinar, experts outline growing complexity of biodiversity compliance for cosmetics and personal care companies

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.

Wayne chats with Deb Autor, CEO of Healthcare Innovation Catalysts, and Paul Offit, M.D., Director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at the Children's Hospital of Philadelphia. You'll hear their thoughts on vaccine development, policy, testing, and funding, including COVID vaccines; the new Commissioner's National Priority Voucher Program; the Sarepta gene therapy episode; leadership transitions at CDER and CBER; AI in pharmaceutical regulation; and much more.

In our headlines segment, Wayne delves into these major developments: 

Pharma: Vinay Prasad back as CBER head after ousting

Devices: Troubles continue with FDA's new AI tool, Elsa

Food: FDA and USDA publish joint RFI to help define ultra-processed foods

Cosmetics: Anxiety over U.S.-imposed tariffs sparks shopper panic in late July

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.

Wayne chats with John Taylor, Head of the Quality and Compliance Practice at ELIQUENT and 30-year FDA, industry, trade association, and consulting veteran. Together, they discuss Taylor's pedigree; his perspective on the most pressing issues FDA is facing in drugs, devices, foods, and cosmetics; the agency's increasing use of AI; what FDA's top priorities should be 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.

Shelly and Wayne chat with the following guests in their respective fields of expertise:

• Pharma: Naomi Lowy, M.D., Principal Drug Regulatory Expert, Hyman, Phelps & McNamara
• Devices: Claire Davies, Shareholder at Polsinelli
• Cosmetics: Angela Diesch, Partner and Head of the Cosmetics Industry Practice at Amin Wasserman Gurnani
• Food: Frank Yiannas, former FDA Deputy Commissioner of Food Policy & Response at FDA

Each guest dives into their top three FDA developments from the first half of 2025 in their respective areas.

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.