Podcast Episodes
Back to SearchPharmaceutical 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
Examining CDRH, Device Innovation & Agency Communication
Season 1 Episode 22
Wayne chats with Sandra Cohen Kalter, member of the Strategic Advisory Group for iTolerance and a retired legal regulatory attorney from industry, …
11 months, 3 weeks ago
A Look at FDA's Drug Review Reset
Season 1 Episode 21
Wayne chats with Cartier Esham, CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA, and Elizabeth Jungman, Partner a…
1 year ago
Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases
Season 1 Episode 20
In this first part of our series in collaboration with Hyman, Phelps & McNamara, P.C. (HPM), Wayne chats with James Valentine, Director at HPM; Fran…
1 year ago
Unpacking OMUFA
Season 1 Episode 19
Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association. You'll hear her though…
1 year, 1 month ago
FDA's Fight Against Ultraprocessed Foods
Season 1 Episode 18
Wayne chats with Claudia Lewis, Co-Chair of the FDA Group at Venable, and Ricardo Carvajal, Director at Hyman, Phelps & McNamara. You'll hear their…
1 year, 1 month ago
Dissecting the Direction of CDER and CBER with Paul Kim
Episode 7
Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies and former head of FDA and federal government strategies practices at a lea…
1 year, 1 month ago
Medical Device Oversight in a Changing Landscape
Season 1 Episode 17
Wayne chats with Neil O'Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani, and Bobbi Druyor-Sanchez, Partner…
1 year, 1 month ago
Vaccines, Pharmaceutical Policy & FDA's Next Moves
Season 1 Episode 16
Wayne chats with Deb Autor, CEO of Healthcare Innovation Catalysts, and Paul Offit, M.D., Director of the Vaccine Education Center and professor of…
1 year, 2 months ago
FDA's Past, Present & Future with John Taylor
Episode 6
Wayne chats with John Taylor, Head of the Quality and Compliance Practice at ELIQUENT and 30-year FDA, industry, trade association, and consulting v…
1 year, 2 months ago