Podcast
FDA Watch
Hosted by FDA Watch · EN
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 host Wayne Pines, former FDA associate commissioner and author/editor of 16 books about FDA. Subscribers to the podcast include regulatory affairs specialists, food and drug attorneys, policymakers, government officials, strategic planners, and IT and cybersecurity professionals.
38episodes
Episodes
Newest firstAll episodes
FDA Reporter Roundtable: A View From the News Desk
Mar 200:53:37Tap to summarizeWayne 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.
Transcribe →'Forever Chemicals' and Cosmetics Oversight in 2026
Feb 2300:42:01Tap to summarizeWayne 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. Music by Dvir Silver from Pixabay.
Transcribe →Medical Device Regulation, Compliance & Policy, Part 2: A Look at Europe & China
Feb 1700:47:39Tap to summarizeIn 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. Music by Dvir Silver from Pixabay.
Transcribe →FDA's 2026 Food Priorities
Feb 900:55:20Tap to summarizeWayne 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. Music by Dvir Silver from Pixabay.
Transcribe →Medical Device Regulation, Compliance & Policy, Part 1: LDTs in Focus
Feb 200:54:32Tap to summarizeIn 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. Music by Dvir Silver from Pixabay.
Transcribe →FDA's Evolving Approach to Medical Device Reviews
Jan 2600:50:21Tap to summarizeWayne 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.
Transcribe →Inside FDA Pharma Policy Development
Jan 1200:45:45Tap to summarizeWayne 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. Music by Dvir Silver from Pixabay.
Transcribe →Year-End Review & Look Ahead
Dec 2200:52:22Tap to summarizeWayne 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.
Transcribe →Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products
Dec 100:32:15Tap to summarizeIn 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.
Transcribe →Key Issues Shaping Cosmetics and Personal Care Oversight
Nov 2400:40:31Tap to summarizeWayne 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.
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