Enter your email below to subscribe to FDA Watch.
You’ll get an email as soon as new episodes are published.
Recent Episodes
-
Cautious Optimism Surrounding Rare Diseases and Orphan Drugs
Wayne chats with Geoffrey Levitt and Frank Sasinowski about 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… Listen ⇢
-
FDA’s Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods
In the third part of our series with Skadden, Wayne chats with Rachel Turow, Milli Hansen, Daniel Luks, and Douglas Stearn about 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… Listen ⇢
-
FDA’s Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices
In the second part of our series with Skadden, Wayne chats with Rachel Turow, Bill Ridgway, Michelle Gasaway, and Carolyn Bruguera about 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… Listen ⇢
-
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 ⇢
-
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 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 ⇢
-
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 ⇢
-
‘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 ⇢
-
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 ⇢
FDA Watch Podcast 