FDA Watch

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 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...

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 wi...

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...

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 an...

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 investmen...

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-...

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 Affair...

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 intersectio...

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 age...

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...

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 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 int...

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 no...

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 mo...

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 fo...

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 "FDA Matters: The Grossman FDA report." You'll hear their thoughts on what to expect from FDA under the new administration,...

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, cyb...

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 issue...

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 FDAWatch.n...