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
How Industry Is Adapting to FDA's Food Shifts
Nov 1700:49:26Tap to summarizeWayne chats with Sarah Sorscher, Director of Regulatory Affairs at the Center for Science in the Public Interest, and Sarah Gallo, Senior Vice President of Product Policy and Federal Affairs at the Consumer Brands Association. You'll hear their thoughts on the current state of foods at FDA, concerns related to the agency's budget, impacts of the government shutdown on FDA and the Human Foods program, how federal regulation might affect state regulation, changes to the GRAS process and post-market review, how industry is adapting to evolving guidance on ultraprocessed foods, and much more. Read Sarah Sorscher's statement and article on the Marshall bill. In our headlines segment, Wayne delves into these major developments: FDA returns to work following historic government shutdown Pharma: Richard Pazdur named new CDER director FDA announces next round of priority review vouchers Devices: MD+DI analysis shows slowdown in device regulatory review process Food: From ProPublica, FDA foreign food safety inspections hit historic low Cosmetics: Neutrogena recalls potentially contaminated makeup wipes 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 →Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs
Nov 1000:46:01Tap to summarizeIn this third part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Sara Koblitz, Director at HPM; Kurt Karst, Director at HPM; and Karin Hessler, General Counsel at the Association for Accessible Medicines. Together, they discuss the biggest hurdles that the generic industry needs to overcome in today's regulatory environment; the effect of pressure on industry to continue lowering drug prices; how the Hatch-Waxman Act has played out over the past 40 years; how the act can be used to address drug shortages; incentives for companies to develop follow-on products to avoid shortages; how tariffs are impacting generic drug manufacturing overseas; 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 →Pharmaceutical Regulation, Compliance & Policy, Part 2: Navigating the New Enforcement Environment
Nov 300:48:35Tap to summarizeIn this second part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with John Claud, Counsel at HPM; Peter Dickos, Counsel at HPM; and Andrew Hull, Director at HPM. Together, they discuss the current enforcement environment at FDA; foreign inspections of pharmaceuticals and how companies should respond to 483s; False Claims Act theories for liability, specifically in areas such as cybersecurity, tariffs, DEI compliance, and CID/subpoena responses; key considerations in determining whether to enter into a consent decree with the agency; trends in enforcement discretion; 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 →Examining CDRH, Device Innovation & Agency Communication
Oct 2700:47:51Tap to summarizeWayne chats with Sandra Cohen Kalter, member of the Strategic Advisory Group for iTolerance and a retired legal regulatory attorney from industry, and Steve Silverman, President of the consultancy The Silverman Group. You'll hear their thoughts on how CDRH has been affected over the past year, whether the center has the resources and cross-agency collaboration it needs to fulfill its regulatory mandate, FDA's capacity to support innovation amid review pressure and staffing cuts, how companies can find reliable up-to-date regulatory information that's not available through FDA communications avenues, FDA's ability to monitor safety and performance throughout a device's life cycle, and much more. In our headlines segment, Wayne delves into these major developments: Pharma: From STAT, biotech leaders say FDA uncertainty threatens drug development Devices: FDA alerts healthcare providers, patients, and caregivers to complications with radiofrequency microneedling devices Food: FDA remains busy with food recalls, this time for cinnamon and eggs Cosmetics: Personal Care Insights spotlights growing wave in cosmetics: human-derived ingredients 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 →A Look at FDA's Drug Review Reset
Oct 2000:45:47Tap to summarizeWayne chats with Cartier Esham, CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA, and Elizabeth Jungman, Partner at Hogan Lovells in the firm's Pharmaceuticals and Biotechnology practice. You'll hear their thoughts on FDA's maintenance of its drug review process amid staffing cuts; the agency's new PreCheck program and how it may proceed; FDA's evolving stance on confirmatory evidence and accelerated approvals and how they could reshape how companies approach clinical trial designs or risk disclosures; agency budgets; ramped-up AI use at the agency and in industry; and much more. In our headlines segment, Wayne delves into these major developments: Pharma: Former CBER Director Dr. Peter Marks joins Eli Lilly Devices: FDA seeks public input on how best to measure and evaluate AI-enabled medical devices Food: FDA continues to investigate Listeria and Salmonella outbreaks across U.S. Cosmetics: Jury awards $966 million to family of deceased California woman, finding that Johnson & Johnson's talc-based baby powder contributed to mesothelioma 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 →Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases
Oct 1600:49:16Tap to summarizeIn this first part of our series in collaboration with Hyman, Phelps & McNamara, P.C. (HPM), Wayne chats with James Valentine, Director at HPM; Frank Sasinowski, Director at HPM; Louise Himmelstrup, Vice President of Regulatory Affairs at Zevra Therapeutics; and Kate McCurdy, Co-Founder and Board Chair of the Barth Syndrome Foundation. Together, they discuss the current status of orphan drug approvals at FDA; why confirmatory evidence is particularly important in rare disease development programs, how confirmatory evidence is being and has been applied, and how confirmatory evidence is evolving; new ways in which sponsors and FDA are engaging with accelerated approvals through greater use of intermediate clinical endpoints; ultra-rare disease pathways, including FDA's new Rare Disease Evidence Principles, and why diseases like Barth syndrome and Niemann-Pick disease type C face such challenges with the agency; 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 →Unpacking OMUFA
Sep 1500:42:17Tap to summarizeWayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association. You'll hear her thoughts on recent FDA warning letters to sunscreen brands; the mention of sunscreens in the new MAHA report; "foodification" risks in beauty and the personal care products space; how companies can prepare for potentially increased agency focus on non-traditional product formats; OMUFA, how it could impact innovation and competition in the OTC space, and its effect on small businesses; and much more. Check out IBA's Cosmetics Convergence Fall 2025: Indie Beauty Compliance Edition, a two-day virtual conference happening Nov. 12–13, for further updates and practical guidance on beauty and personal care industry compliance. FDA Watch listeners get 10% off registration with discount code IBAFDA10. In our headlines segment, Wayne delves into these major developments: HHS issues new MAHA report President Trump signs executive order regarding DTC advertising; FDA Commissioner Makary sends letters to pharma companies saying new rules and stricter enforcement coming Pharma and Devices: OMB releases Spring 2025 regulatory agenda Food: FDA launches new Nationalized Entry Review program Cosmetics: EU bans gel nail polishes that continue to be sold in U.S. 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 →FDA's Fight Against Ultraprocessed Foods
Sep 800:44:15Tap to summarizeWayne chats with Claudia Lewis, Co-Chair of the FDA Group at Venable, and Ricardo Carvajal, Director at Hyman, Phelps & McNamara. You'll hear their thoughts on FDA's focus and direction on ultraprocessed foods; GRAS regulation and former FDA Commissioner Dr. David Kessler's citizen petition; potential agency updates to food nutrition labeling; inspections and food safety; FDA's use of AI in food decision-making; and much more. In our headlines segment, Wayne delves into these major developments: Pharma: Substantial publicity surrounds firing of CDC Director Susan Monarez Devices: FDA launces Regulatory Accelerator for digital health devices Food: HHS and Secretary Kennedy to issue second MAHA report Cosmetics: FDA issues warning letters to sunscreen companies making mousse products 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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