FDA Watch
FDA Watch
Podcast Description
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 the co-hosts: Wayne Pines, former FDA associate commissioner and author/editor of 16 books about FDA, and Shelly Garg, principal at Garg Law, an FDA-focused law firm and a frequent writer on FDA issues. Subscribers to the podcast include regulatory affairs specialists, food and drug attorneys, policymakers, government officials, strategic planners, and IT and cybersecurity professionals.
Podcast Insights
Content Themes
The podcast centers on four primary topics: pharmaceuticals and biologics, medical devices and diagnostics, food and dietary supplements, and cosmetics and personal care products. Recent episodes have covered significant subjects such as MoCRA, the regulation of food safety under the new administration, and key issues in device regulation, emphasizing practical and policy analysis.
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.
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 sunscreens in the new MAHA report; “foodification” risks in beauty and the personal care products space; how companies can prepare for potentially increased agency focus on non-traditional product formats; OMUFA, how it could impact innovation and competition in the OTC space, and its effect on small businesses; and much more.
Check out IBA’s Cosmetics Convergence Fall 2025: Indie Beauty Compliance Edition, a two-day virtual conference happening Nov. 12–13, for further updates and practical guidance on beauty and personal care industry compliance. FDA Watch listeners get 10% off registration with discount code IBAFDA10.
In our headlines segment, Wayne delves into these major developments:
HHS issues new MAHA report
President Trump signs executive order regarding DTC advertising; FDA Commissioner Makary sends letters to pharma companies saying new rules and stricter enforcement coming
Pharma and Devices: OMB releases Spring 2025 regulatory agenda
Food: FDA launches new Nationalized Entry Review program
Cosmetics: EU bans gel nail polishes that continue to be sold in U.S.
In our Resource Links segment, we list key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.
Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at [email protected].
Music by Dvir Silver from Pixabay.
Disclaimer
This podcast’s information is provided for general reference and was obtained from publicly accessible sources. The Podcast Collaborative neither produces nor verifies the content, accuracy, or suitability of this podcast. Views and opinions belong solely to the podcast creators and guests.
For a complete disclaimer, please see our Full Disclaimer on the archive page. The Podcast Collaborative bears no responsibility for the podcast’s themes, language, or overall content. Listener discretion is advised. Read our Terms of Use and Privacy Policy for more details.