FDA Watch Podcast

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Recent Episodes

  • FDA’s Regulatory Revisions: Business & Legal Impact on Industry, Part 1 – Pharmaceuticals

    In Part 1 of our series with Skadden, Wayne chats with Rachel Turow, Raquel Fox, Kendall Ickes, and Tess Cameron about 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… Listen ⇢

    FDA’s Regulatory Revisions: Business & Legal Impact on Industry, Part 1 – Pharmaceuticals

  • Medical Device Regulation, Compliance & Policy, Part 4: Digital Health & Consumers

    In this fourth and final part of our series with Covington, Wayne chats with Kristin Davenport, Christina Kuhn, Olivia Dworkin, and Jackie Haydock about 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… Listen ⇢

    Medical Device Regulation, Compliance & Policy, Part 4: Digital Health & Consumers

  • 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, Michael Granston, and Krysten Rosen Moller about 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;… Listen ⇢

    Medical Device Regulation, Compliance & Policy, Part 3: On False Claims

  • FDA Reporter Roundtable: A View From the News Desk

    Wayne chats with Lizzy Lawrence, Derrick Gingery, and Sarah Karlin-Smith about overarching themes surrounding FDA coverage today; how access to FDA decision-makers and frontline staff has changed; FDA’s tendency to announce policies via video announcements and press releases instead of through official guidances; how reporters decide what gets media attention;… Listen ⇢

    FDA Reporter Roundtable: A View From the News Desk

  • ‘Forever Chemicals’ and Cosmetics Oversight in 2026

    Wayne chats with Rend Al-Mondhiry and Will Woodlee about FDA’s recent PFAS report; how FDA and Congress might work toward addressing PFAS and other “forever chemicals”; challenges associated with state versus federal oversight on cosmetic ingredients; how the implementation of MoCRA could be changing the regulatory landscape for cosmetic companies;… Listen ⇢

    ‘Forever Chemicals’ and Cosmetics Oversight in 2026

  • Medical Device Regulation, Compliance & Policy, Part 2: A Look at Europe & China

    In the second episode of our series with Covington, Wayne chats with Sarah Cowlishaw, John Balzano, and Julia Post about 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… Listen ⇢

    Medical Device Regulation, Compliance & Policy, Part 2: A Look at Europe & China

  • FDA’s 2026 Food Priorities

    Wayne chats with David Lennarz and Dr. Susan Mayne about 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… Listen ⇢

    FDA’s 2026 Food Priorities

  • Medical Device Regulation, Compliance & Policy, Part 1: LDTs in Focus

    In Part 1 of our series with Covington, Wayne chats with Amy Leiser, Scott Danzis, and Susan Van Meter about the history of 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… Listen ⇢

    Medical Device Regulation, Compliance & Policy, Part 1: LDTs in Focus

  • FDA’s Evolving Approach to Medical Device Reviews

    Wayne chats with Mike Ryan and Michael Gaba about the relationship between FDA and the device industry; 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;… Listen ⇢

    FDA’s Evolving Approach to Medical Device Reviews