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FDA Watch

Podcast FDA Watch
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...

Available Episodes

5 of 11
  • 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 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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  • 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 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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  • 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 FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at [email protected].
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  • The Evolution of Clinical Trials
    Shelly and Wayne chat with Steve Grossman, President of HPS Group and author of “FDA Matters: The Grossman FDA report,” 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 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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  • 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 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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About 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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