# FDA Watch A podcast by 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. Feed: https://rss.libsyn.com/shows/557121/destinations/4811141.xml ## Latest episodes - [What's Ahead for FDA & MedTech](https://invisiblenetwork.ai/podcast/1784517503/5cf06e8bf62e) (2026-10-26, 51 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep34_Final.mp3?dest-id=4811141 - [FDA Legal, Regulatory & Compliance Issues, Part 4: Mergers & Acquisitions](https://invisiblenetwork.ai/podcast/1784517503/d805f635c9bd) (2026-10-22, 43 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_AGG4_Final.mp3?dest-id=4811141 - [The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals](https://invisiblenetwork.ai/podcast/1784517503/1e3fea62dd16) (2026-10-19, 44 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_AGPart3_Final.mp3?dest-id=4811141 - [The Rise of Real-World Evidence in Regulatory Strategy, Part 2: RWE in Medical Devices](https://invisiblenetwork.ai/podcast/1784517503/9f57cb34abbc) (2026-10-15, 44 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_AGPart2_Final.mp3?dest-id=4811141 - [An Evolving Direction for Drug Oversight](https://invisiblenetwork.ai/podcast/1784517503/fea5d85b00a5) (2026-10-12, 34 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep33_Final.mp3?dest-id=4811141 - [The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development](https://invisiblenetwork.ai/podcast/1784517503/e0c16ce63d50) (2026-09-21, 47 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_AGPart1_Final.mp3?dest-id=4811141 - [What's Actually Happening in Cosmetics & Personal Care](https://invisiblenetwork.ai/podcast/1784517503/efe363b41619) (2026-09-14, 46 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep32_Final2.mp3?dest-id=4811141 - [Food Safety in the Spotlight](https://invisiblenetwork.ai/podcast/1784517503/4253a1d36a47) (2026-09-08, 50 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep31_Final.mp3?dest-id=4811141 - [FDA Legal, Regulatory & Compliance Issues, Part 3: Advertising & Promotion](https://invisiblenetwork.ai/podcast/1784517503/14066f3c812e) (2026-08-17, 47 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_AGG3_Final.mp3?dest-id=4811141 - [Keeping Up with Medical Device Manufacturing and Digital Health](https://invisiblenetwork.ai/podcast/1784517503/078d85e34f54) (2026-08-10, 48 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep30_Final.mp3?dest-id=4811141 - [An Extensive Breakdown of the Pharmaceutical and Biologics Landscape](https://invisiblenetwork.ai/podcast/1784517503/0d7da60138cc) (2026-08-03, 49 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep29_Final.mp3?dest-id=4811141 - [FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade](https://invisiblenetwork.ai/podcast/1784517503/e8837f2db4d0) (2026-07-27, 40 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_AGG2_Final.mp3?dest-id=4811141 - [FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement](https://invisiblenetwork.ai/podcast/1784517503/d7c819055fae) (2026-07-20, 42 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_AGG1_Final.mp3?dest-id=4811141 - [Midyear Review: 2026 So Far & a Look Forward](https://invisiblenetwork.ai/podcast/1784517503/b8010f8f41ab) (2026-07-13, 51 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_BE13_Final2.mp3?dest-id=4811141 - [From Price Strategy to Enforcement Risk](https://invisiblenetwork.ai/podcast/1784517503/2e93acac01ee) (2026-07-06, 45 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_WCBRG3_Final.mp3?dest-id=4811141 - [When Pricing Pressure Reaches the FDA File: Practical FDA Realities](https://invisiblenetwork.ai/podcast/1784517503/adfc2361c196) (2026-06-15, 43 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_WCBRG2_Final.mp3?dest-id=4811141 - [Governmental Policy Levers: Navigating Drug Pricing Across Agencies and Congress](https://invisiblenetwork.ai/podcast/1784517503/878263cdaad4) (2026-06-08, 54 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_WCBRG1_Final.mp3?dest-id=4811141 - [FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 4 – Consumer Products](https://invisiblenetwork.ai/podcast/1784517503/90e59b2fb81b) (2026-06-01, 41 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Skadden4_Final.mp3?dest-id=4811141 - [Breaking Down FDA's Proposed FY27 Budget](https://invisiblenetwork.ai/podcast/1784517503/6f634c423a7c) (2026-05-28, 31 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_BE12_Final.mp3?dest-id=4811141 - [What's Next for Cosmetics and Personal Care Products?](https://invisiblenetwork.ai/podcast/1784517503/803445a8a585) (2026-05-26, 48 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep28_Final.mp3?dest-id=4811141 - [A Fresh Look at the State of Human Foods](https://invisiblenetwork.ai/podcast/1784517503/b15a965a012d) (2026-05-18, 49 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep27_Final.mp3?dest-id=4811141 - [Where Does FDA Go From Here?](https://invisiblenetwork.ai/podcast/1784517503/8124add812dd) (2026-05-15, 35 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_BE11_Final.mp3?dest-id=4811141 - [Insights on Evidence and Communication with FDA in Device Submissions](https://invisiblenetwork.ai/podcast/1784517503/b00074c6b887) (2026-05-04, 46 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep26_Final.mp3?dest-id=4811141 - [Cautious Optimism Surrounding Rare Diseases and Orphan Drugs](https://invisiblenetwork.ai/podcast/1784517503/2bd2fd87c755) (2026-04-27, 47 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep25_Final.mp3?dest-id=4811141 - [FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods](https://invisiblenetwork.ai/podcast/1784517503/e9967e2d1b2b) (2026-04-20, 44 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Skadden3_Final.mp3?dest-id=4811141 - [FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices](https://invisiblenetwork.ai/podcast/1784517503/7f6fc543267f) (2026-03-30, 37 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Skadden2_Final.mp3?dest-id=4811141 - [FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 1 – Pharmaceuticals](https://invisiblenetwork.ai/podcast/1784517503/5ceee2702f02) (2026-03-23, 50 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Skadden1_Final.mp3?dest-id=4811141 - [Medical Device Regulation, Compliance & Policy, Part 4: Digital Health & Consumers](https://invisiblenetwork.ai/podcast/1784517503/523f4e332911) (2026-03-16, 47 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Cov4_Final.mp3?dest-id=4811141 - [Medical Device Regulation, Compliance & Policy, Part 3: On False Claims](https://invisiblenetwork.ai/podcast/1784517503/0b1aa96b6ad1) (2026-03-09, 40 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Cov3_Final.mp3?dest-id=4811141 - [FDA Reporter Roundtable: A View From the News Desk](https://invisiblenetwork.ai/podcast/1784517503/91f5c47d43e0) (2026-03-02, 54 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_BE10_Final.mp3?dest-id=4811141 - ['Forever Chemicals' and Cosmetics Oversight in 2026](https://invisiblenetwork.ai/podcast/1784517503/0619d4d77eef) (2026-02-23, 43 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep24_Final.mp3?dest-id=4811141 - [Medical Device Regulation, Compliance & Policy, Part 2: A Look at Europe & China](https://invisiblenetwork.ai/podcast/1784517503/cca7eafd0cb9) (2026-02-17, 48 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Cov2_Final.mp3?dest-id=4811141 - [FDA's 2026 Food Priorities](https://invisiblenetwork.ai/podcast/1784517503/40f0b3fe330d) (2026-02-09, 56 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep23_Final.mp3?dest-id=4811141 - [Medical Device Regulation, Compliance & Policy, Part 1: LDTs in Focus](https://invisiblenetwork.ai/podcast/1784517503/bb57ac240fce) (2026-02-02, 55 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Cov1_Final.mp3?dest-id=4811141 - [FDA's Evolving Approach to Medical Device Reviews](https://invisiblenetwork.ai/podcast/1784517503/6c6eb3fa2d26) (2026-01-26, 51 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep22_Final.mp3?dest-id=4811141 - [Inside FDA Pharma Policy Development](https://invisiblenetwork.ai/podcast/1784517503/f540c9d93bb8) (2026-01-12, 46 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep21_Final.mp3?dest-id=4811141 - [Year-End Review & Look Ahead](https://invisiblenetwork.ai/podcast/1784517503/8d68c9fd3da5) (2025-12-22, 53 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_BE9_Final.mp3?dest-id=4811141 - [Deregulation, AI & More with Dr. Ritu Nalubola](https://invisiblenetwork.ai/podcast/1784517503/0ab2aadb77a3) (2025-12-08, 46 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_BE8_Final.mp3?dest-id=4811141 - [Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products](https://invisiblenetwork.ai/podcast/1784517503/53b35a5bcc90) (2025-12-01, 33 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_HPMPart4_Final.mp3?dest-id=4811141 - [Key Issues Shaping Cosmetics and Personal Care Oversight](https://invisiblenetwork.ai/podcast/1784517503/689a2263a744) (2025-11-24, 41 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep20_Final.mp3?dest-id=4811141 - [How Industry Is Adapting to FDA's Food Shifts](https://invisiblenetwork.ai/podcast/1784517503/4e8a0fa42c05) (2025-11-17, 50 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep19_Final.mp3?dest-id=4811141 - [Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs](https://invisiblenetwork.ai/podcast/1784517503/890b288dda27) (2025-11-10, 47 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_HPMPart3_Final.mp3?dest-id=4811141 - [Pharmaceutical Regulation, Compliance & Policy, Part 2: Navigating the New Enforcement Environment](https://invisiblenetwork.ai/podcast/1784517503/39b87b1c9fe6) (2025-11-03, 49 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_HPMPart2_Final.mp3?dest-id=4811141 - [Examining CDRH, Device Innovation & Agency Communication](https://invisiblenetwork.ai/podcast/1784517503/b494012803a6) (2025-10-27, 48 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep18_Final.mp3?dest-id=4811141 - [A Look at FDA's Drug Review Reset](https://invisiblenetwork.ai/podcast/1784517503/2f07945c2a83) (2025-10-20, 46 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep17_Final.mp3?dest-id=4811141 - [Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases](https://invisiblenetwork.ai/podcast/1784517503/f785592b376b) (2025-10-16, 50 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_HPMPart1_Final.mp3?dest-id=4811141 - [Unpacking OMUFA](https://invisiblenetwork.ai/podcast/1784517503/64d5ba6c8b73) (2025-09-15, 43 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep16_Final.mp3?dest-id=4811141 - [FDA's Fight Against Ultraprocessed Foods](https://invisiblenetwork.ai/podcast/1784517503/49aa51dc78d5) (2025-09-08, 45 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep15_Final.mp3?dest-id=4811141 - [Dissecting the Direction of CDER and CBER with Paul Kim](https://invisiblenetwork.ai/podcast/1784517503/c68637a2acd9) (2025-09-02, 42 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_BE7_Final.mp3?dest-id=4811141 - [Medical Device Oversight in a Changing Landscape](https://invisiblenetwork.ai/podcast/1784517503/e811306f204e) (2025-08-26, 52 min): audio https://traffic.libsyn.com/secure/6686a1d2-366f-4e2e-8fe5-b70c2a33e3ef/FDA_Ep14_Final.mp3?dest-id=4811141 Shows are listed from Apple Podcasts' charts and directory, and Podcast Index where it is used. Every show and episode belongs to its publisher and plays from the publisher's own feed; this site hosts none of them.