Podcast Episodes
Back to SearchThe Rise of Real-World Evidence in Regulatory Strategy, Part 2: RWE in Medical Devices
Season 1 Episode 56
In this second part of our new series in collaboration with Analysis Group, Wayne chats with Dr. Mary Beth Ritchey, Principal of Med Tech Epi LLC, a…
9 hours ago
An Evolving Direction for Drug Oversight
Season 1 Episode 55
Wayne chats with Brian Malkin, Partner at Spencer Fane. You'll hear Brian's thoughts on potential FDA leadership under Heidi Overton, early prioriti…
3 days, 8 hours ago
The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development
Season 1 Episode 54
In this first part of our new series in collaboration with Analysis Group, Wayne chats with Dr. James Signorovitch, Managing Principal at Analysis G…
3 weeks, 3 days ago
What's Actually Happening in Cosmetics & Personal Care
Season 1 Episode 53
Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association, and Claire Bing, CEO an…
1 month ago
Food Safety in the Spotlight
Season 1 Episode 52
Wayne chats with Mason Weeda, Managing Principal at OFW Law and Chair of the firm's FDA Food Practice, and Jessica O'Connell, Partner at Covington a…
1 month, 1 week ago
FDA Legal, Regulatory & Compliance Issues, Part 3: Advertising & Promotion
Season 1 Episode 51
In this third part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Alan Minsk, Partner, Chair of the Food & Drug pra…
1 month, 4 weeks ago
Keeping Up with Medical Device Manufacturing and Digital Health
Season 1 Episode 50
Wayne chats with Cathy Burgess, Partner and Head of the FDA Compliance and Enforcement Team and FDA Practice at Alston & Bird, and Michael Gaba, Food…
2 months ago
An Extensive Breakdown of the Pharmaceutical and Biologics Landscape
Season 1 Episode 49
Wayne chats with Daniel Kracov, Partner and Chair of the Life Sciences Industry Group at Arnold & Porter, and Dr. Gayatri Rao, Director at Hyman, Ph…
2 months, 1 week ago
FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade
Season 1 Episode 48
In this second part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Luis Arandia Jr., Partner and Co-chair of Intern…
2 months, 2 weeks ago
FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement
Season 1 Episode 47
In this first part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Gabriel Scannapieco, Partner at AGG and Co-chair …
2 months, 3 weeks ago