A New Era of Unprecedented Change
FDA Watch
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...
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The Latest in FDA’s Focus on Foods
FDA Watch
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...
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What’s Happening in Software and Device Regulation
FDA Watch
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...
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The Evolution of Clinical Trials
FDA Watch
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...
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Navigating FDA’s Future: Janet Woodcock on the Evolving Regulatory Landscape
FDA Watch
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...
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A Deep Dive Into MoCRA
FDA Watch
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:...
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Food Regulation and Safety Under the New Administration
FDA Watch
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...
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The New-Look FDA: What’s on the Horizon?
FDA Watch
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...
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What’s Coming in Device, Cybersecurity, and Digital Health Product Regulation
FDA Watch
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...
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Key Pharmaceutical Regulation Issues for the New Administration
FDA Watch
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...
info_outlineIn 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 FDAWatch.net.
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Music by Dvir Silver from Pixabay.