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FDA Watch

FDA Watch

73 episodes

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.

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  1. What's Ahead for FDA & MedTech

    · 50 min · S1 E59

    Wayne 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 hear their takeaways from AdvaMed's…

  2. FDA Legal, Regulatory & Compliance Issues, Part 4: Mergers & Acquisitions

    · 43 min · S1 E58

    In 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 of the Life Sciences industry team at…

  3. The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals

    · 43 min · S1 E57

    In 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 and CEO of Kodiak Strategic…

  4. The Rise of Real-World Evidence in Regulatory Strategy, Part 2: RWE in Medical Devices

    · 44 min · S1 E56

    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, and Associate Research Professor at Rutgers University; and Cori…

  5. An Evolving Direction for Drug Oversight

    · 34 min · S1 E55

    Wayne 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 companies, implications for drug pricing, AI…

  6. The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development

    · 46 min · S1 E54

    In 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, Regulatory Partner at White & Case; and Dr.…

  7. What's Actually Happening in Cosmetics & Personal Care

    · 46 min · S1 E53

    Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association, and Claire Bing, CEO and Founder of Confiance Cosmetic Group. You'll hear their thoughts on…

  8. Food Safety in the Spotlight

    · 50 min · S1 E52

    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 and Co-Chair of the firm's Food, Drug, and Device Practice Group.…

  9. FDA Legal, Regulatory & Compliance Issues, Part 3: Advertising & Promotion

    · 46 min · S1 E51

    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 practice, and Co-chair of the Life Sciences industry team at AGG; and…

  10. Keeping Up with Medical Device Manufacturing and Digital Health

    · 48 min · S1 E50

    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 and Drug Vice Chair at Polsinelli. You'll hear their thoughts on…

  11. An Extensive Breakdown of the Pharmaceutical and Biologics Landscape

    · 48 min · S1 E49

    Wayne 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 their thoughts on Operation TrialBlazer;…

  12. FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade

    · 40 min · S1 E48

    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 International Trade at AGG, and Allison Raley, Partner in AGG's Corporate &…

  13. FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement

    · 41 min · S1 E47

    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 of the firm's Life Sciences industry team. Together, they discuss…

  14. Midyear Review: 2026 So Far & a Look Forward

    · 50 min · Episode 13 · Bonus

    Wayne 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 FDA's Center for Food Safety and Applied…

  15. From Price Strategy to Enforcement Risk

    · 45 min · S1 E46

    In 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 Buthusiem, Managing Director at BRG.…

  16. When Pricing Pressure Reaches the FDA File: Practical FDA Realities

    · 42 min · S1 E45

    In 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. Together, they discuss where pricing…

  17. Governmental Policy Levers: Navigating Drug Pricing Across Agencies and Congress

    · 54 min · S1 E44

    In 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 White & Case's Washington, D.C., office; and…

  18. FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 4 – Consumer Products

    · 41 min · S1 E43

    In 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 Litigation Practice; Brett Fleisher, M&A…

  19. Breaking Down FDA's Proposed FY27 Budget

    · 30 min · Episode 12 · Bonus

    Wayne 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 budget, examine how it compares with past…

  20. What's Next for Cosmetics and Personal Care Products?

    · 47 min · S1 E42

    Wayne chats with Jessica O'Connell, Partner at Covington and Co-Chair of the firm's Food, Drug, and Device Practice Group; and Rebecca Dandeker, Partner in the Food and Drug Practice at Wiley Rein. You'll hear their…

  21. A Fresh Look at the State of Human Foods

    · 48 min · S1 E41

    Wayne chats with Brian Sylvester, Partner in Morrison Foerster's FDA and Healthcare Regulatory and Compliance Group, and Scott Faber, Senior Vice President of Government Affairs for the Environmental Working Group.…

  22. Where Does FDA Go From Here?

    · 35 min · Episode 11 · Bonus

    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…

  23. Insights on Evidence and Communication with FDA in Device Submissions

    · 46 min · S1 E40

    Wayne chats with Mark DuVal, CEO of DuVal & Associate; Bryan Feldhaus, President of DuVal & Associates; and Chris Lyle, Vice President of Evidence Strategy at DuVal & Associates. You'll hear their thoughts on what's…

  24. Cautious Optimism Surrounding Rare Diseases and Orphan Drugs

    · 47 min · S1 E39

    Wayne chats with Geoffrey Levitt, Head of Global Regulatory Law at argenx, and Frank Sasinowski, Director at Hyman, Phelps & McNamara. You'll hear their thoughts on the recently introduced plausible mechanism framework…

  25. FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods

    · 43 min · S1 E38

    In the third part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Milli Hansen, Partner in Skadden's Mass Torts, Insurance and Consumer Litigation…

  26. FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices

    · 36 min · S1 E37

    In the second part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Bill Ridgway, Co-Head of Skadden's Global Cybersecurity and Data Privacy…

  27. FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 1 – Pharmaceuticals

    · 49 min · S1 E36

    In this first part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Raquel Fox, Head of Skadden's U.S. ESG Practice and Co-Head of the firm's SEC…

  28. Medical Device Regulation, Compliance & Policy, Part 4: Digital Health & Consumers

    · 47 min · S1 E35

    In this fourth and final part of our series in collaboration with Covington, Wayne chats with Kristin Davenport, Christina Kuhn, and Olivia Dworkin, Attorneys at Covington; and Jackie Haydock, Chief Healthcare…

  29. Medical Device Regulation, Compliance & Policy, Part 3: On False Claims

    · 39 min · S1 E34

    In this third part of our series in collaboration with Covington, Wayne chats with Pam Forrest, Partner and Co-Chair of Covington's Medical Device Industry Group; Michael Granston, Partner and Chair of Covington's…

  30. FDA Reporter Roundtable: A View From the News Desk

    · 54 min · Episode 10 · Bonus

    Wayne chats with Lizzy Lawrence, Lead FDA Reporter at STAT; Derrick Gingery, Executive Editor for U.S. Regulatory and Policy Insights at The Pink Sheet; and Sarah Karlin-Smith, Research Director at Public Citizen's…

  31. 'Forever Chemicals' and Cosmetics Oversight in 2026

    · 42 min · S1 E33

    Wayne chats with Rend Al-Mondhiry, Co-Chair of the Regulatory Practice Group at Amin Wasserman Gurnani, and Will Woodlee, Managing Partner at Kleinfeld, Kaplan & Becker. You'll hear their thoughts on FDA's recent…

  32. Medical Device Regulation, Compliance & Policy, Part 2: A Look at Europe & China

    · 48 min · S1 E32

    In this second part of our series in collaboration with Covington, Wayne chats with Sarah Cowlishaw, Partner in Covington's European Food, Drug and Device Practice; John Balzano, Partner in Covington's China Food, Drug…

  33. FDA's 2026 Food Priorities

    · 55 min · S1 E31

    Wayne chats with David Lennarz, President of Registrar Corp., and Dr. Susan Mayne, Adjunct Professor at the Yale School of Public Health and former Director of FDA's Center for Food Safety and Applied Nutrition. You'll…

  34. Medical Device Regulation, Compliance & Policy, Part 1: LDTs in Focus

    · 55 min · S1 E30

    In this first part of our series in collaboration with Covington, Wayne chats with Amy Leiser, Special Counsel at Covington; Scott Danzis, Partner at Covington; and Susan Van Meter, President of the American Clinical…

  35. FDA's Evolving Approach to Medical Device Reviews

    · 50 min · S1 E29

    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 Polsinelli. You'll hear their thoughts on where the relationship between…

  36. Inside FDA Pharma Policy Development

    · 46 min · S1 E28

    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 thoughts on how FDA policy is developed and is evolving; how previous…

  37. Year-End Review & Look Ahead

    · 52 min · Episode 9

    Wayne chats with the following guests in their respective fields of expertise: Pharma: Paul Kim, Principal, Kendall Square Policy Strategies LLC Devices: John Sawyer, President, Realistic Quality Solutions, LLC…

  38. Deregulation, AI & More with Dr. Ritu Nalubola

    · 46 min · Episode 8 · Bonus

    Wayne chats with Dr. Ritu Nalubola, Director of Life Sciences and Healthtech at Marwood Group and former FDA leader, spanning several roles over more than two decades. Together, they discuss how deregulation has been…

  39. Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products

    · 32 min · S1 E27

    In this fourth and final part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Michelle Butler, Director at HPM; Charles Raver, Associate at HPM; and Josephine Torrente, Director at…

  40. Key Issues Shaping Cosmetics and Personal Care Oversight

    · 41 min · S1 E26

    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 at FDA in cosmetics and personal care products; how companies should…

  41. How Industry Is Adapting to FDA's Food Shifts

    · 49 min · S1 E25

    Wayne chats with Sarah Sorscher, Director of Regulatory Affairs at the Center for Science in the Public Interest, and Sarah Gallo, Senior Vice President of Product Policy and Federal Affairs at the Consumer Brands…

  42. Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs

    · 46 min · S1 E24

    In this third part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Sara Koblitz, Director at HPM; Kurt Karst, Director at HPM; and Karin Hessler, General Counsel at the Association…

  43. Pharmaceutical Regulation, Compliance & Policy, Part 2: Navigating the New Enforcement Environment

    · 49 min · S1 E23

    In this second part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with John Claud, Counsel at HPM; Peter Dickos, Counsel at HPM; and Andrew Hull, Director at HPM. Together, they…

  44. Examining CDRH, Device Innovation & Agency Communication

    · 48 min · S1 E22

    Wayne chats with Sandra Cohen Kalter, member of the Strategic Advisory Group for iTolerance and a retired legal regulatory attorney from industry, and Steve Silverman, President of the consultancy The Silverman Group.…

  45. A Look at FDA's Drug Review Reset

    · 46 min · S1 E21

    Wayne chats with Cartier Esham, CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA, and Elizabeth Jungman, Partner at Hogan Lovells in the firm's Pharmaceuticals and Biotechnology…

  46. Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases

    · 49 min · S1 E20

    In this first part of our series in collaboration with Hyman, Phelps & McNamara, P.C. (HPM), Wayne chats with James Valentine, Director at HPM; Frank Sasinowski, Director at HPM; Louise Himmelstrup, Vice President of…

  47. Unpacking OMUFA

    · 42 min · S1 E19

    Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association. You'll hear her thoughts on recent FDA warning letters to sunscreen brands; the mention of…

  48. FDA's Fight Against Ultraprocessed Foods

    · 44 min · S1 E18

    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 thoughts on FDA's focus and direction on ultraprocessed foods; GRAS…

  49. Dissecting the Direction of CDER and CBER with Paul Kim

    · 42 min · Episode 7 · Bonus

    Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies and former head of FDA and federal government strategies practices at a leading law firm for 20 years. Together, they discuss major legal issues…

  50. Medical Device Oversight in a Changing Landscape

    · 52 min · S1 E17

    Wayne chats with Neil O'Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani, and Bobbi Druyor-Sanchez, Partner with NDA Partners. You'll hear their thoughts on what's happening at…

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