Podcast Episodes
Back to SearchMedical Device Regulation, Compliance & Policy, Part 1: LDTs in Focus
Season 1 Episode 30
In this first part of our series in collaboration with Covington, Wayne chats with Amy Leiser, Special Counsel at Covington; Scott Danzis, Partner a…
8 months, 2 weeks ago
FDA's Evolving Approach to Medical Device Reviews
Season 1 Episode 29
Wayne chats with Mike Ryan, Executive Vice President at ELIQUENT and former FDA staffer at CDRH, and Michael Gaba, Food and Drug Vice Chair at Pols…
8 months, 3 weeks ago
Inside FDA Pharma Policy Development
Season 1 Episode 28
Wayne chats with Rumi Young, Director of Regulatory Policy at Novo Nordisk, and Jamie Gamerman, Head of Regulatory Policy at UCB. You'll hear their…
9 months ago
Year-End Review & Look Ahead
Episode 9
Wayne chats with the following guests in their respective fields of expertise:
Pharma: Paul Kim, Principal, Kendall Square Policy Strategies LLC
…
9 months, 3 weeks ago
Deregulation, AI & More with Dr. Ritu Nalubola
Episode 8
Wayne chats with Dr. Ritu Nalubola, Director of Life Sciences and Healthtech at Marwood Group and former FDA leader, spanning several roles over mor…
10 months, 1 week ago
Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products
Season 1 Episode 27
In this fourth and final part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Michelle Butler, Director at HPM;…
10 months, 2 weeks ago
Key Issues Shaping Cosmetics and Personal Care Oversight
Season 1 Episode 26
Wayne chats with Rachel Raphael, Partner at Morgan Lewis, and Ronie Schmelz, Partner at K&L Gates. You'll hear their thoughts on what's happening…
10 months, 3 weeks ago
How Industry Is Adapting to FDA's Food Shifts
Season 1 Episode 25
Wayne chats with Sarah Sorscher, Director of Regulatory Affairs at the Center for Science in the Public Interest, and Sarah Gallo, Senior Vice Pres…
11 months ago
Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs
Season 1 Episode 24
In this third part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Sara Koblitz, Director at HPM; Kurt Karst, D…
11 months, 1 week ago
Pharmaceutical Regulation, Compliance & Policy, Part 2: Navigating the New Enforcement Environment
Season 1 Episode 23
In this second part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with John Claud, Counsel at HPM; Peter Dickos, C…
11 months, 2 weeks ago