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Recent Episodes
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What’s Next for Cosmetics and Personal Care Products?
Wayne chats with Jessica O’Connell and Rebecca Dandeker about the recent leadership changes at FDA; unanswered questions for the cosmetics industry as they move into long-term compliance with FDA’s MoCRA requirements; the agency’s draft guidance on its mandatory recall authority for cosmetics; how companies should be thinking risk management amid… Listen ⇢
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A Fresh Look at the State of Human Foods
Wayne chats with Brian Sylvester and Scott Faber about the recent appointment of Kyle Diamantas to Acting Head of FDA; the direction and drivers of food regulation; the phase-out of synthetic food dyes amid growing state-level action; where FDA’s interest in overhauling GRAS stands; the potential formal definition of “ultraprocessed”… Listen ⇢
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Where Does FDA Go From Here?
Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies LLC, and Stuart Pape, Senior Partner and Food and Drug Chair at Polsinelli. Together, they discuss the resignation of Dr. Marty Makary as FDA Commissioner, the installment of former Deputy Commissioner of Human Foods Kyle Diamantas as Acting Head… Listen ⇢
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Insights on Evidence and Communication with FDA in Device Submissions
Wayne chats with Mark DuVal, Bryan Feldhaus, and Chris Lyle about 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… Listen ⇢
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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 ⇢
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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 ⇢
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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 ⇢
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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 ⇢
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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 ⇢
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