FDA Watch
by FDA Watch
Latest episode
The Rise of Real-World Evidence in Regulatory Strategy, Part 4: RWE…
The Rise of Real-World Evidence in Regulatory Strategy, Part 4: RWE…
About this podcast
FDA Watch is a twice-monthly, national podcast that provides an independent, non-partisan forum for discussing and understanding the latest developments, trends, and issues involving FDA. The podcast focuses on four core areas: pharmaceuticals and biologics; medical devices and diagnostics; food and dietary supplements; and cosmetics and personal care products, as well as on the overall direction of FDA regulation. The podcast also will have bonus episodes to cover breaking news. Podcast guests analyze FDA regulations, guidances, and policy developments and engage in insightful and revealing conversations with host Wayne Pines, former FDA associate commissioner and author/editor of 16 books about FDA. Subscribers to the podcast include regulatory affairs specialists, food and drug attorneys, policymakers, government officials, strategic planners, and IT and cybersecurity professionals.
Episodes
The newest 20 of 74 episodes
- The Rise of Real-World Evidence in Regulatory Strategy, Part 4: RWE in Postmarketing Studies · 43 min · Season 1 Episode 60In this fourth part of our series in collaboration with Analysis Group, Wayne chats with Dr. Marianne Cunnington, Managing Principal at Analysis Group, and Dr. Robert Reynolds…
- What's Ahead for FDA & MedTech · 50 min · Season 1 Episode 59Wayne chats with Philip Desjardins, Partner at Arnold & Porter; Sean Boyd, Corporate Vice President at QualityHub; and Rusty Segan, CEO of Medical & Scientific Advisors. You'll…
- FDA Legal, Regulatory & Compliance Issues, Part 4: Mergers & Acquisitions · 43 min · Season 1 Episode 58In this fourth and final part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-chair…
- The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals · 43 min · Season 1 Episode 57In this third part of our series in collaboration with Analysis Group, Wayne chats with Dr. Maral DerSarkissian, Managing Principal at Analysis Group; Dr. Mark Robbins, President…
- The Rise of Real-World Evidence in Regulatory Strategy, Part 2: RWE in Medical Devices · 44 min · Season 1 Episode 56In 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, and Associate Research…
- An Evolving Direction for Drug Oversight · 34 min · Season 1 Episode 55Wayne chats with Brian Malkin, Partner at Spencer Fane. You'll hear Brian's thoughts on potential FDA leadership under Heidi Overton, early priorities for drug and biologics…
- The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development · 46 min · Season 1 Episode 54In this first part of our new series in collaboration with Analysis Group, Wayne chats with Dr. James Signorovitch, Managing Principal at Analysis Group; Bethany Hills…
- What's Actually Happening in Cosmetics & Personal Care · 46 min · Season 1 Episode 53Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association, and Claire Bing, CEO and Founder of Confiance…
- Food Safety in the Spotlight · 50 min · Season 1 Episode 52Wayne 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 and Co-Chair of the firm's…
- FDA Legal, Regulatory & Compliance Issues, Part 3: Advertising & Promotion · 46 min · Season 1 Episode 51In this third part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-chair of the…
- Keeping Up with Medical Device Manufacturing and Digital Health · 48 min · Season 1 Episode 50Wayne chats with Cathy Burgess, Partner and Head of the FDA Compliance and Enforcement Team and FDA Practice at Alston & Bird, and Michael Gaba, Food and Drug Vice Chair at…
- An Extensive Breakdown of the Pharmaceutical and Biologics Landscape · 48 min · Season 1 Episode 49Wayne chats with Daniel Kracov, Partner and Chair of the Life Sciences Industry Group at Arnold & Porter, and Dr. Gayatri Rao, Director at Hyman, Phelps & McNamara. You'll hear…
- FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade · 40 min · Season 1 Episode 48In this second part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Luis Arandia Jr., Partner and Co-chair of International Trade at AGG, and…
- FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement · 41 min · Season 1 Episode 47In this first part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Gabriel Scannapieco, Partner at AGG and Co-chair of the firm's Life Sciences…
- Midyear Review: 2026 So Far & a Look Forward · 50 min · Episode 13Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies LLC, and Dr. Susan Mayne, Adjunct Professor at the Yale School of Public Health and former Director of…
- From Price Strategy to Enforcement Risk · 45 min · Season 1 Episode 46In this third and final part of our series in collaboration with White & Case and BRG, Wayne chats with Lauren Papenhausen, Partner at White & Case's Boston office, and Edward…
- When Pricing Pressure Reaches the FDA File: Practical FDA Realities · 42 min · Season 1 Episode 45In this second part of our series in collaboration with White & Case and BRG, Wayne chats with Bethany Hills, Partner at White & Case, and Dan Troy, Managing Director at BRG…
- Governmental Policy Levers: Navigating Drug Pricing Across Agencies and Congress · 54 min · Season 1 Episode 44In this first part of our series in collaboration with White & Case and BRG, Wayne chats with Bethany Hills, Partner at White & Case's New York office; Rahul Rao, Partner in…
- FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 4 – Consumer Products · 41 min · Season 1 Episode 43In the final part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's Regulatory Practice; Amy Van Gelder, Head of Skadden's Chicago…
- Breaking Down FDA's Proposed FY27 Budget · 30 min · Episode 12Wayne chats with Dr. Cartier Esham, CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA. Together, they discuss FDA's proposed fiscal year 2027…
