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Recent Episodes
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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 ⇢
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‘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 ⇢
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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 ⇢
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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 ⇢
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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 ⇢
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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 ⇢
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Inside FDA Pharma Policy Development
Wayne chats with Rumi Young and Jamie Gamerman about how FDA policy is developed, how previous PDUFAs have changed the agency’s policy agenda, the most important inflection points driving FDA policy, the development of new agency frameworks, FDA’s efforts to balance scientific integrity with regulatory flexibility in policy development, and… Listen ⇢
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Year-End Review & a Look Ahead
Wayne chats with Paul Kim, John Sawyer, Stuart Pape, and Angela Diesch. 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. Listen ⇢
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Deregulation, AI & More with Dr. Ritu Nalubola
Wayne chats with Dr. Ritu Nalubola about how deregulation has been playing out at FDA, industry incentive programs, how agency efforts to streamline regulation could affect product safety, the agency’s role in regulating AI and supporting AI applications, broader initiatives on health data and governance, where things may be headed… Listen ⇢
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