FDA Watch
FDA Watch is a twice-monthly, national podcast that provides an independent, non-partisan forum for discussing and understanding the latest developments, trends, and issues involving FDA. The podcast focuses on four core areas: pharmaceuticals and biologics; medical devices and diagnostics; food and dietary supplements; and cosmetics and personal care products, as well as on the overall direction of FDA regulation. The podcast also will have bonus episodes to cover breaking news. Podcast guests analyze FDA regulations, guidances, and policy developments and engage in insightful and revealing conversations with the co-hosts: Wayne Pines, former FDA associate commissioner and author/editor of 16 books about FDA, and Shelly Garg, principal at Garg Law, an FDA-focused law firm and a frequent writer on FDA issues. Subscribers to the podcast include regulatory affairs specialists, food and drug attorneys, policymakers, government officials, strategic planners, and IT and cybersecurity professionals.
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Breaking Down Cosmetics Safety, Imports & MoCRA
06/02/2025
Breaking Down Cosmetics Safety, Imports & MoCRA
Shelly and Wayne chat with Emily Manoso, Executive Vice President, Legal & Regulatory Affairs, and General Counsel at the Personal Care Products Council. You’ll hear her thoughts on the state of cosmetics regulation and safety under the new administration, cosmetic and personal care product imports, the implementation and enforcement of MoCRA, FDA’s fragrance allergen labeling rule, and much more. In our headlines segment, Shelly and Wayne delve into these major developments: HHS and FDA launch public request for information to identify and eliminate outdated or unnecessary regulations Pharma: FDA shifts position on COVID-19 vaccines Devices: FDA approves first at-home cervical cancer testing kit Food: FDA launches “more robust, transparent” post-market chemical review program for food Cosmetics: FDA issues warning on contaminated tattoo inks 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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AI, Medical Products & FDA, Part 3: AI in Drug & Device Commercialization
05/27/2025
AI, Medical Products & FDA, Part 3: AI in Drug & Device Commercialization
In this third and final part of our AI series in collaboration with Arnold & Porter, Shelly and Wayne chat with Philip Desjardins, Partner at Arnold & Porter; Mahnu Davar, Partner at Arnold & Porter; and Dr. William Maisel, Vice President and Senior Medical Officer at Intuitive, and former Director of the Office of Product Evaluation and Quality at the Center for Devices and Radiological Health at FDA. Together, they discuss the use of AI for clinical decision support, in regulation and pharmacovigilance functions, and in diagnostic and monitoring tools; AI’s impact on advertising and promotion; what “AI washing” is and why it’s important to distinguish real AI innovation from marketing hype; FDA’s first AI-assisted scientific review pilot; and much more. Access Arnold & Porter’s recent AI survey 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Homing in on Food Supply, Tariffs & Infant Formula
05/26/2025
Homing in on Food Supply, Tariffs & Infant Formula
Shelly and Wayne chat with Martin Hahn, Global Regulatory Partner at Hogan Lovells, and Tony Pavel, Partner at Keller and Heckman. You’ll hear their thoughts on global food supply chain vulnerabilities and how FDA is monitoring them; how U.S. tariffs on imported food products influence the availability and safety oversight of essential goods like formula or medical nutrition; how FDA is working with international partners to improve coordination and transparency; FDA measures to ensure a more resilient and responsive infant formula supply; and much more. In our Headlines segment, Shelly and Wayne delve into these major developments: FDA announces expanded use of unannounced inspections at foreign manufacturing facilities President Trump signs an executive order that aims to reduce drug costs by basing payments for certain medicines on their prices in other countries Pharma: FDA Commissioner Dr. Marty Makary says layoffs won’t hinder the agency’s target dates for drug reviews Devices: Two U.S. Senators introduce legislation encouraging the use of AI-enabled medical devices Food: HHS, FDA announce plans to phase out synthetic dyes in nation’s food supply Cosmetics: ICCS shares case studies and mock dossiers as examples of how new approach methodologies can be utilized 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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AI, Medical Products & FDA, Part 2: AI Discovery, Design & Development
05/01/2025
AI, Medical Products & FDA, Part 2: AI Discovery, Design & Development
In this second part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Howard Sklamberg, Partner at Arnold & Porter; Eva Temkin, Partner at Arnold & Porter; and Marko Topalovic, Chief AI Officer at Clario, which recently acquired ArtiQ, where he was Founder and CEO. Together, they discuss how AI can accelerate drug discovery and design; how AI could be used in the clinical trial process; how FDA could use AI to evaluate medical product manufacturers’ data integrity operations and in inspections; how AI could play a part in product applications; and much more. Access Arnold & Porter’s recent AI survey . 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Devices, Disruption & the Road Ahead
04/28/2025
Devices, Disruption & the Road Ahead
Shelly and Wayne chat with Dr. Daniel Schultz, Principal of Medical Devices and Combination Products at Eliquent, and Jonathan Kahan, a Global Regulatory Partner at Hogan Lovells. You’ll hear their thoughts on the effect of CDRH staff reductions on medical device reviews and market authorizations; the outlook for device regulation in the next few years; how FDA is responding to device shortages and supply interruptions; the effectiveness of the current post-market surveillance system in detecting device-related adverse events; the possible effect of eliminating the Freedom of Information staff on the agency’s ability to be responsive and transparent to the public; and much more. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: Drug development is decelerating amid FDA’s staffing cuts Devices: A federal court shuts down an FDA rule that reclassifies laboratory services as medical devices Food: FDA did not disclose information surrounding fatal E. coli outbreak linked to lettuce Cosmetics: PCPC releases statement following FDA’s announcement to phase out animal testing requirements for monoclonal antibodies and other drugs 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Breaking Down Pharma in the Current Environment
04/21/2025
Breaking Down Pharma in the Current Environment
Shelly and Wayne chat with Dr. Michelle McMurry-Heath, Founder and CEO of BioTechquity Clinical, and Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-Chair of the Life Sciences industry team at Arnall Golden Gregory LLP. You’ll hear their thoughts on the potential effects that FDA staffing cuts may have on drug and biologics approvals; how the current environment may affect investments in drug and biotech development; what companies can do to amid agency staffing shortages; how FDA can aim to include all demographics of patients in trials; and much more. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: Trump administration makes exception for pharmaceuticals amid rollout of tariffs Devices: Industry continues to face the consequences of cutbacks at CDRH Food: Food company completes FDA pre-market consultation for human food made with cultured pork fat cells Cosmetics: PCPC executive issues statement on impact of Trump administration’s reciprocal tariffs on cosmetics and personal care products industry 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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The State of Protection, Innovation & Communication at FDA
04/17/2025
The State of Protection, Innovation & Communication at FDA
Shelly and Wayne chat with Ron Bartek, Co-Founder and President of Friedreich’s Ataxia Research Alliance, and Ralph Hall, CEO of Hall Strategies, LLC. Together, they discuss the overall situation at FDA right now; its impact on agency activities and innovation; what areas will be most impacted; what policy changes, such as those surrounding vaccines, animal testing, expedited approvals, and right-to-try guidance, might be coming; 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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AI, Medical Products & FDA, Part 1: AI Overview in Life Sciences
04/15/2025
AI, Medical Products & FDA, Part 1: AI Overview in Life Sciences
In this first part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Dan Kracov, Partner at Arnold and Porter and Chair of the firm’s Global Life Sciences Industry group; Abeba Habtemariam, Partner at Arnold & Porter; Ethan Dabbs, Managing Director and Senior Partner at the Boston Consulting Group; and Lauren Silvis, Senior Vice President of External Affairs at Tempus. Together, they discuss Arnold & Porter’s recent survey on AI adoption in life sciences; problems, challenges, and successes in AI adoption in drug and medical device development; where FDA may be hampered in developing AI policy given budget and personnel cuts; concerns surrounding AI and protecting IP; and much more. Access Arnold & Porter’s survey on AI adoption in life sciences at 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Examining the Cosmetics Compliance and Enforcement Landscape
04/07/2025
Examining the Cosmetics Compliance and Enforcement Landscape
Shelly and Wayne chat with Justin Prochnow, Partner in the Denver office of Greenberg Traurig. You’ll hear his thoughts on what FDA could be prioritizing in cosmetics and personal care products under new FDA Commissioner Dr. Marty Makary; compliance and enforcement obstacles the agency is facing with MoCRA implementation; challenges companies are facing from class-action attorneys; the intersection of cosmetics and environmental regulation; and much more. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: FDA will not require an Advisory Committee meeting for a new fibromyalgia treatment, potentially streamlining its approval process Medical Devices: Advocacy group says FDA should regulate “dangerous” prescription software platform as a medical device Food: FDA pushes back the compliance date of the Food Safety Modernization Act Section 204(d) Cosmetics: From Fortune, beauty industry giants plead with European Union to exclude American cosmetics from tariff war 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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A New Era of Unprecedented Change
04/01/2025
A New Era of Unprecedented Change
Shelly and Wayne chat with Nancy Myers, CEO of Catalyst Healthcare Consulting, Inc., and former Special Assistant and Senior Strategic Advisor in FDA’s Office of the Commissioner, and Stuart Pape, Senior Partner and Chair of the FDA Practice at Polsinelli. Together, they discuss what companies should be doing now amid changes at FDA, including the recent confirmation of Dr. Marty Makary as the agency’s new commissioner; the potential effect of the agency’s consolidation of backroom functions such as IT and HR; what it means for FDA to lose such leaders as Drs. Peter Marks and Patrizia Cavazzoni; the impact of staffing reductions on inspections; and much more. This episode and all future bonus episodes do not include the usual Headlines and Resources Links segments. To subscribe or find out more information about our podcast, visit . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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The Latest in FDA’s Focus on Foods
03/31/2025
The Latest in FDA’s Focus on Foods
Shelly and Wayne chat with 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, and Dr. Peter Lurie, President of the Center for Science in the Public Interest and former Associate Commissioner at FDA. You’ll hear their thoughts on what incoming FDA Commissioner Dr. Marty Makary may be prioritizing in the food space, why it took FDA so long to ban Red Dye No. 3, the agency’s “healthy” claim final rule, where FDA stands with reducing sodium in human foods, the push to eliminate the self-affirmed GRAS pathway, and much more. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: Drugs and biologics continue to be reviewed in a timely way, meeting the PDUFA dates, despite recent disruption Medical Devices: CDRH has been busy with device recalls lately, two of which were labeled as Class I Food: HHS Secretary Robert F. Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe Cosmetics: PCPC Applauds Reintroduction of Humane 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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What’s Happening in Software and Device Regulation
03/17/2025
What’s Happening in Software and Device Regulation
Shelly and Wayne chat with Jennifer Newberger, Director at Hyman Phelps, and Michael Gaba, Vice Chair of the FDA practice at Polsinelli. You’ll hear their thoughts on how to interact with FDA officials under the new administration; anticipated changes in the review and approval of PMAs, 510ks, and de novo applications; clinical trial requirements for SaMD; and much more. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: FDA approves Merilog, a biosimilar to Novolog for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus Medical Devices: Lobby Urges HHS To Rethink Trump’s FDA CutsFood: 2.4 Million Cases of Popular Granola Bars Recalled Due to ‘Potential Presence of Metal’Cosmetics: PCPC President & CEO Tom Myers Discusses how the Beauty Industry is Innovating with AI, Sustainability, and Transparency 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at .
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The Evolution of Clinical Trials
03/03/2025
The Evolution of Clinical Trials
Shelly and Wayne chat with Steve Grossman, President of HPS Group and author of and Anthony Brogno, Director of Clinical Operations at Lindus Health. You’ll hear their thoughts on how drug development, drug approvals, and clinical trials could be evolving under the new administration’s FDA; priorities in clinical trails for the new FDA Commissioner; the intersection of budget and the FDA’s use of artificial intelligence in its review systems; and much more. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: FDA Holds Virtual Public Workshop on Cell Therapies and Tissue-Based Products Devices: FDA Issues the Center for Devices and Radiological Health (CDRH) 2024 Annual Report Food: FDA Publishes New Food Contamination Prevention Strategy Cosmetics: FDA Plan on Banning Certain Hair-Straightening Chemicals in Limbo In our Resource Links segment, we listed key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Navigating FDA’s Future: Janet Woodcock on the Evolving Regulatory Landscape
02/17/2025
Navigating FDA’s Future: Janet Woodcock on the Evolving Regulatory Landscape
Shelly and Wayne chat with Janet Woodcock, M.D., former FDA Principal Deputy Commissioner. Woodcock shares her expert insights on the agency’s approach to navigating the current regulatory environment, the increasing role of artificial intelligence in FDA decision-making, and the future of the agency’s staffing, resources, and regulatory frameworks. This episode and all future bonus episodes do not include the usual Headlines and Resource Links segments. To subscribe or find out more information about our podcast, visit . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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A Deep Dive Into MoCRA
02/10/2025
A Deep Dive Into MoCRA
In this episode, Shelly and Wayne chat with Will Woodlee, Managing Partner at Kleinfeld, Kaplan & Becker, LLP, and David Lennarz, President of Registrar Corp. You’ll hear their thoughts on the top priorities in cosmetics regulation for the next FDA Commissioner and their insights on all things MoCRA, including how it intersects with ingredient transparency and the clean beauty movement, how the modernized framework might be enforced, and its overall impact on businesses, consumers, and industry. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: Commissioner Califf Reflects on COVID-19 Devices: AdvaMed Praises Congressional AI Task Force Food: FDA Amends Color Additive Regulations for FD&C Red No. 3 Cosmetics: PCPC Webinar Focuses on Sustainability In our Resource Links segment, we listed key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Food Regulation and Safety Under the New Administration
02/03/2025
Food Regulation and Safety Under the New Administration
In this episode, Shelly and Wayne chat with Stuart Pape, Senior Partner and Chair of the FDA Practice at Polsinelli, and Domenic Veneziano, Independent FDA Regulatory and Strategic Consultant and Owner of Veneziano Consulting. You’ll hear their thoughts on the top priorities in food regulation for the next FDA Commissioner and their insights on increased FSVP inspections, key issues surrounding food importation, the Human Foods program, and other top-of-mind issues. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: FDA Issues Final Rule on Non-Prescription Drug ProductsDevices: FDA Answers Questions on Clinical Decision Support Software FunctionsFood: FDA Finalizes Updates “Healthy” Nutrient Content ClaimCosmetics: FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc In our Resource Links segment, we listed key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at .
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The New-Look FDA: What’s on the Horizon?
01/20/2025
The New-Look FDA: What’s on the Horizon?
In this episode, Shelly and Wayne chat with Marc Scheineson, a former FDA Associate Commissioner and currently Senior Counsel in the Washington, D.C., office of Alston & Bird; and Steven Grossman, President of HPS Group, a policy and regulatory consulting firm, and author of You’ll hear their thoughts on what to expect from FDA under the new administration, including the transition process, Robert F. Kennedy Jr.’s role, staffing issues, funding, possible changes in standards for safety and efficacy, the fate of user fees, and more. This episode and all future bonus episodes do not include the usual Headlines and Resources Links segments. To subscribe or find out more information about our podcast, visit . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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What’s Coming in Device, Cybersecurity, and Digital Health Product Regulation
01/13/2025
What’s Coming in Device, Cybersecurity, and Digital Health Product Regulation
In this episode, Shelly and Wayne chat with Neil O’Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani LLP, and John Swayer, President of Realistic Quality Solutions, LLC. You’ll hear their thoughts on the top priorities in medical device regulation for the next FDA Commissioner and their insights on laboratory-developed tests, the transition to ISO 13485, cybersecurity guidance and regulation, and digital health product regulation. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: FDA Issues Draft Guidance on Accelerated Approval of Drugs for Serious Conditions Devices: FDA Publishes Report on Risks and Benefits to Health of Non-Device Software Functions Food: USDA and FDA Announce Joint Request for Info on Food Date Labeling Cosmetics: FDA Updates Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products In our Resource Links segment, we listed key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Key Pharmaceutical Regulation Issues for the New Administration
01/06/2025
Key Pharmaceutical Regulation Issues for the New Administration
In our first episode, Shelly and Wayne chat with Nikki Reeves, Partner in the FDA & Life Sciences practice at King & Spalding, and Brian Malkin, Associate General Counsel for Regulatory Law at Teva Pharmaceuticals. You’ll hear their thoughts on the top priorities in pharmaceutical regulation for the next FDA commissioner and their insights on AI policy, patient voices, and other front-burner issues. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: More than 200,000 Prescriptions for Wegovy Filled Devices: FDA Announces Communication Pilot on Recalls Food: Fruits & Vegetables: Are They Really Safe? Cosmetics: FDA Issue Final Rule on Color Additive Certification Fees In our Resource Links segment, we listed key documents in our fore core areas. To view these links, subscribe, or find out more information about our podcast, visit . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Trailer
12/11/2024
Trailer
Welcome to FDA Watch, a twice-monthly, national podcast that provides an independent, non-partisan forum for discussing and understanding the latest developments, trends, and issues involving FDA. Hosts Shelly Garg and Wayne Pines will dive into compelling conversations with a diverse array of FDA-focused professionals, who shed light on the developments shaping the future of FDA. Visit to subscribe today! Music by from .
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