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FDA Watch

FDA Watch

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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Episodes

74 episodes

  1. The Rise of Real-World Evidence in Regulatory Strategy, Part 4: RWE in Postmarketing Studies 43:09
  2. What's Ahead for FDA & MedTech 50:20
  3. FDA Legal, Regulatory & Compliance Issues, Part 4: Mergers & Acquisitions 42:57
  4. The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals 43:17
  5. The Rise of Real-World Evidence in Regulatory Strategy, Part 2: RWE in Medical Devices 43:49
  6. An Evolving Direction for Drug Oversight 33:30
  7. The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development 46:28
  8. What's Actually Happening in Cosmetics & Personal Care 45:44
  9. Food Safety in the Spotlight 49:42
  10. FDA Legal, Regulatory & Compliance Issues, Part 3: Advertising & Promotion 46:05
  11. Keeping Up with Medical Device Manufacturing and Digital Health 47:59
  12. An Extensive Breakdown of the Pharmaceutical and Biologics Landscape 48:25
  13. FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade 39:30
  14. FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement 41:03
  15. Midyear Review: 2026 So Far & a Look Forward 50:01
  16. From Price Strategy to Enforcement Risk 44:38
  17. When Pricing Pressure Reaches the FDA File: Practical FDA Realities 42:04
  18. Governmental Policy Levers: Navigating Drug Pricing Across Agencies and Congress 53:52
  19. FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 4 – Consumer Products 40:37
  20. Breaking Down FDA's Proposed FY27 Budget 30:27
  21. What's Next for Cosmetics and Personal Care Products? 47:12
  22. A Fresh Look at the State of Human Foods 48:03
  23. Where Does FDA Go From Here? 34:36
  24. Insights on Evidence and Communication with FDA in Device Submissions 45:42
  25. Cautious Optimism Surrounding Rare Diseases and Orphan Drugs 46:53
  26. FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods 43:24
  27. FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices 36:19
  28. FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 1 – Pharmaceuticals 49:22
  29. Medical Device Regulation, Compliance & Policy, Part 4: Digital Health & Consumers 46:56
  30. Medical Device Regulation, Compliance & Policy, Part 3: On False Claims 39:06
  31. FDA Reporter Roundtable: A View From the News Desk 53:37
  32. 'Forever Chemicals' and Cosmetics Oversight in 2026 42:01
  33. Medical Device Regulation, Compliance & Policy, Part 2: A Look at Europe & China 47:39
  34. FDA's 2026 Food Priorities 55:20
  35. Medical Device Regulation, Compliance & Policy, Part 1: LDTs in Focus 54:32
  36. FDA's Evolving Approach to Medical Device Reviews 50:21
  37. Inside FDA Pharma Policy Development 45:45
  38. Year-End Review & Look Ahead 52:22
  39. Deregulation, AI & More with Dr. Ritu Nalubola 45:36
  40. Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products 32:15
  41. Key Issues Shaping Cosmetics and Personal Care Oversight 40:31
  42. How Industry Is Adapting to FDA's Food Shifts 49:26
  43. Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs 46:01
  44. Pharmaceutical Regulation, Compliance & Policy, Part 2: Navigating the New Enforcement Environment 48:35
  45. Examining CDRH, Device Innovation & Agency Communication 47:51
  46. A Look at FDA's Drug Review Reset 45:47
  47. Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases 49:16
  48. Unpacking OMUFA 42:17
  49. FDA's Fight Against Ultraprocessed Foods 44:15
  50. Dissecting the Direction of CDER and CBER with Paul Kim 41:32