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 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.
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Insights on Evidence and Communication with FDA in Device Submissions
05/04/2026
Insights on Evidence and Communication with FDA in Device Submissions
Wayne chats with Mark DuVal, CEO of DuVal & Associate; Bryan Feldhaus, President of DuVal & Associates; and Chris Lyle, Vice President of Evidence Strategy at DuVal & Associates. You’ll hear their thoughts on what’s happening right now at FDA and in the medical device industry; whether companies should engage FDA early in the pre-submission process or make their case in the actual submission; common breakdowns in the submission process; the importance of real-world evidence and where companies can still fall short; holding FDA to a consistent standard after initial feedback; and much more. In our headlines segment, Wayne highlights these major developments: Pharma: FDA reports progress after first year of roadmap to reduce animal testing in drug development Devices: CDRH issues letter to combination product manufacturers with information on potential nitrosamine impurities Food: FDA issues warning letters to food companies following serious violations Cosmetics: FDA releases Grand Rounds presentation recording featuring experts from Office of Cosmetics and Colors 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Cautious Optimism Surrounding Rare Diseases and Orphan Drugs
04/27/2026
Cautious Optimism Surrounding Rare Diseases and Orphan Drugs
Wayne chats with Geoffrey Levitt, Head of Global Regulatory Law at argenx, and Frank Sasinowski, Director at Hyman, Phelps & McNamara. You’ll hear their thoughts on the recently introduced plausible mechanism framework for individualized therapies in ultra-rare diseases; where FDA is making meaningful progress for rare-disease sponsors and where gaps persist; the agency’s willingness to exercise regulatory flexibility in rare diseases; recent experiences in dealing with FDA on orphan drugs; how the agency has fared in translating concepts such as historical data, real-world evidence, and patient engagement into review decisions; and much more. In our headlines segment, Wayne highlights these major developments: Pharma: FDA-backed proposals aim to entice pharma companies to test and produce drugs domestically Devices: FDA launches READI-Home Innovation Challenge Food: FDA seeking public input on potential market name change for 18 species of rockfish Cosmetics: Processors must complete first biennial FDA facility registration renewals by July 1, as required under MoCRA 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 . . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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FDA’s Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods
04/20/2026
FDA’s Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods
In the third part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden’s FDA Regulatory Practice; Milli Hansen, Partner in Skadden’s Mass Torts, Insurance and Consumer Litigation Group; Daniel Luks, Partner in Skadden’s Mergers & Acquisitions Practice; and Douglas Stearn, Principal at Canal Row Advisors. Together, they discuss the latest developments in food regulation at FDA and at the state level; how companies may want to prepare for potential FDA and state enforcement actions and policy shifts in the coming year; how the regulatory environment impacts litigation; how regulatory uncertainty and litigation affect M&A deals; how companies can navigate the evolving food environment; 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by Dvir Silver from Pixabay.
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FDA’s Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices
03/30/2026
FDA’s Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices
In the second part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden’s FDA Regulatory Practice; Bill Ridgway, Co-Head of Skadden’s Global Cybersecurity and Data Privacy Practice; Michelle Gasaway, Partner in Skadden’s Capital Markets Practice; and Carolyn Bruguera, Vice President and General Counsel at the Medical Device Manufacturers Association. Together, they discuss considerations for companies who manufacture, design and/or develop medical devices, including general wellness devices, regarding whether to submit a 510(k); how to proactively prepare for and anticipate complex regulatory, diligence and disclosure issues in preparing for a public offering, private financing or other transaction; the intersection of FDA regulation, privacy law, and cybersecurity in AI for wellness and medical devices; cybersecurity False Claims Act risk for technology and life sciences companies; privacy considerations for those who collect information from wellness and medical devices; what companies in the space should watch for; 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by Dvir Silver from Pixabay.
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FDA’s Regulatory Revisions: Business & Legal Impact on Industry, Part 1 – Pharmaceuticals
03/23/2026
FDA’s Regulatory Revisions: Business & Legal Impact on Industry, Part 1 – Pharmaceuticals
In this first part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden’s FDA Regulatory Practice; Raquel Fox, Head of Skadden’s U.S. ESG Practice and Co-Head of the firm’s SEC Reporting and Compliance Practice; Kendall Ickes, Associate in Skadden’s Intellectual Property and Technology Practice; and Tess Cameron, Managing Director on the Venture Team at RA Capital Management. Together, they discuss helping pharmaceutical and biotech industry clients navigate the uncertain regulatory environment; how FDA is expanding its scope of responsibility; staffing and policy changes at FDA and how they impact the review process; considerations from an SEC disclosure perspective for how companies talk about their product development; protections and assurances buyers may be looking for in the deal context; 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by Dvir Silver from Pixabay.
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Medical Device Regulation, Compliance & Policy, Part 4: Digital Health & Consumers
03/16/2026
Medical Device Regulation, Compliance & Policy, Part 4: Digital Health & Consumers
In this fourth and final part of our series in collaboration with Covington, Wayne chats with Kristin Davenport, Christina Kuhn, and Olivia Dworkin, Attorneys at Covington; and Jackie Haydock, Chief Healthcare Compliance Officer and Associate General Counsel at Meta. Together, they discuss the evolving landscape of digital health worldwide; FDA’s revised guidance on general wellness as it relates to digital health and consumerism; considerations for consumer product companies as they enter the regulated health space; regulatory challenges with multifunction products; what’s on the horizon for FDA and industry in digital health and AI; 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Medical Device Regulation, Compliance & Policy, Part 3: On False Claims
03/09/2026
Medical Device Regulation, Compliance & Policy, Part 3: On False Claims
In this third part of our series in collaboration with Covington, Wayne chats with Pam Forrest, Partner and Co-Chair of Covington’s Medical Device Industry Group; Michael Granston, Partner and Chair of Covington’s False Claims Act Investigations and Litigation practice; and Krysten Rosen Moller, Partner in Covington’s Life Sciences Enforcement practice. Together, they discuss the government’s current use of the False Claims Act to pursue healthcare fraud; issues that could lead to potential False Claims Act liability for medical device manufacturers; preventive actions device manufacturers can take to reduce enforcement exposure; cases challenging the constitutionality of the act’s whistleblower provisions; developments in the government’s ability to pursue False Claims Act liability for kickbacks; 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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FDA Reporter Roundtable: A View From the News Desk
03/02/2026
FDA Reporter Roundtable: A View From the News Desk
Wayne 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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‘Forever Chemicals’ and Cosmetics Oversight in 2026
02/23/2026
‘Forever Chemicals’ and Cosmetics Oversight in 2026
Wayne 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Medical Device Regulation, Compliance & Policy, Part 2: A Look at Europe & China
02/17/2026
Medical Device Regulation, Compliance & Policy, Part 2: A Look at Europe & China
In 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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FDA’s 2026 Food Priorities
02/09/2026
FDA’s 2026 Food Priorities
Wayne 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Medical Device Regulation, Compliance & Policy, Part 1: LDTs in Focus
02/02/2026
Medical Device Regulation, Compliance & Policy, Part 1: LDTs in Focus
In 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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FDA’s Evolving Approach to Medical Device Reviews
01/26/2026
FDA’s Evolving Approach to Medical Device Reviews
Wayne 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: 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Inside FDA Pharma Policy Development
01/12/2026
Inside FDA Pharma Policy Development
Wayne 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Year-End Review & Look Ahead
12/22/2025
Year-End Review & Look Ahead
Wayne 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 . Music by from .
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Deregulation, AI & More with Dr. Ritu Nalubola
12/08/2025
Deregulation, AI & More with Dr. Ritu Nalubola
Wayne chats with Dr. Ritu Nalubola, Director of Life Sciences and Healthtech at Marwood Group and former FDA leader, spanning several roles over more than two decades. Together, they discuss how deregulation has been playing out at FDA; industry incentive programs, such as the Commissioner’s National Priority Voucher program and PreCheck program; how agency efforts to streamline regulation could affect product safety; how tariffs and MFN impact FDA and industry; the agency’s role in regulating AI and supporting AI applications; broader initiatives on health data and governance; Ritu’s thoughts on where things may be headed in 2026; 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products
12/01/2025
Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products
In 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Key Issues Shaping Cosmetics and Personal Care Oversight
11/24/2025
Key Issues Shaping Cosmetics and Personal Care Oversight
Wayne 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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How Industry Is Adapting to FDA’s Food Shifts
11/17/2025
How Industry Is Adapting to FDA’s Food Shifts
Wayne 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 and 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs
11/10/2025
Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs
In 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Pharmaceutical Regulation, Compliance & Policy, Part 2: Navigating the New Enforcement Environment
11/03/2025
Pharmaceutical Regulation, Compliance & Policy, Part 2: Navigating the New Enforcement Environment
In 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Examining CDRH, Device Innovation & Agency Communication
10/27/2025
Examining CDRH, Device Innovation & Agency Communication
Wayne 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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A Look at FDA’s Drug Review Reset
10/20/2025
A Look at FDA’s Drug Review Reset
Wayne 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases
10/16/2025
Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases
In 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Unpacking OMUFA
09/15/2025
Unpacking OMUFA
Wayne 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 , 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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FDA’s Fight Against Ultraprocessed Foods
09/08/2025
FDA’s Fight Against Ultraprocessed Foods
Wayne 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Dissecting the Direction of CDER and CBER with Paul Kim
09/02/2025
Dissecting the Direction of CDER and CBER with Paul Kim
Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies and former head of FDA and federal government strategies practices at a leading law firm for 20 years. Together, they discuss major legal issues and concerns with what the agency is aiming to accomplish; priorities for CDER Director Dr. George Tidmarsh and CBER Director Dr. Vinay Prasad; the direction of CDER and CBER on orphan drugs, rare diseases, and vaccines; reviews under the Commissioner’s National Priority Voucher Program; 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Medical Device Oversight in a Changing Landscape
08/26/2025
Medical Device Oversight in a Changing Landscape
Wayne chats with Neil O’Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani, and Bobbi Druyor-Sanchez, Partner with NDA Partners. You’ll hear their thoughts on what’s happening at CDRH with warning letters and inspections for medical devices, AI-enabled medical devices and the ongoing situation with Whoop, and much more. In our headlines segment, Wayne delves into these major developments: FDA releases new staff manual on “Gold Standard Science” policy Pharma: U.S. District Court upholds FDA authority to regulate homeopathic drugs as “new drugs” under the FD&C Act Pharma: HHS brings back task force on childhood vaccines Devices: FDA declares PFAS in medical devices safe Food: FDA issues warning about imported cookware that may leach lead into food Cosmetics: In recent webinar, experts outline growing complexity of biodiversity compliance for cosmetics and personal care companies 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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Vaccines, Pharmaceutical Policy & FDA’s Next Moves
08/11/2025
Vaccines, Pharmaceutical Policy & FDA’s Next Moves
Wayne chats with Deb Autor, CEO of Healthcare Innovation Catalysts, and Paul Offit, M.D., Director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia. You’ll hear their thoughts on vaccine development, policy, testing, and funding, including COVID vaccines; the new Commissioner’s National Priority Voucher Program; the Sarepta gene therapy episode; leadership transitions at CDER and CBER; AI in pharmaceutical regulation; and much more. In our headlines segment, Wayne delves into these major developments: Pharma: Vinay Prasad back as CBER head after ousting Devices: Troubles continue with FDA’s new AI tool, Elsa Food: FDA and USDA publish joint RFI to help define ultra-processed foods Cosmetics: Anxiety over U.S.-imposed tariffs sparks shopper panic in late July 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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FDA’s Past, Present & Future with John Taylor
08/07/2025
FDA’s Past, Present & Future with John Taylor
Wayne chats with John Taylor, Head of the Quality and Compliance Practice at ELIQUENT and 30-year FDA, industry, trade association, and consulting veteran. Together, they discuss Taylor’s pedigree; his perspective on the most pressing issues FDA is facing in drugs, devices, foods, and cosmetics; the agency’s increasing use of AI; what FDA’s top priorities should be 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 . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at . Music by from .
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