What’s Coming in Device, Cybersecurity, and Digital Health Product Regulation
Release Date: 01/13/2025
What’s Coming in Device, Cybersecurity, and Digital Health Product Regulation
FDA Watch
In this episode, Shelly and Wayne chat with Neil O’Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani LLP, and John Swayer, President of Realistic Quality Solutions, LLC. You’ll hear their thoughts on the top priorities in medical device regulation for the next FDA Commissioner and their insights on laboratory-developed tests, the transition to ISO 13485, cybersecurity guidance and regulation, and digital health product regulation. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: FDA Issues Draft Guidance on...
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Key Pharmaceutical Regulation Issues for the New Administration
FDA Watch
In our first episode, Shelly and Wayne chat with Nikki Reeves, Partner in the FDA & Life Sciences practice at King & Spalding, and Brian Malkin, Associate General Counsel for Regulatory Law at Teva Pharmaceuticals. You’ll hear their thoughts on the top priorities in pharmaceutical regulation for the next FDA commissioner and their insights on AI policy, patient voices, and other front-burner issues. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: More than 200,000 Prescriptions for Wegovy Filled Devices: FDA Announces Communication Pilot on...
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Trailer
FDA Watch
Welcome to FDA Watch, a twice-monthly, national podcast that provides an independent, non-partisan forum for discussing and understanding the latest developments, trends, and issues involving FDA. Hosts Shelly Garg and Wayne Pines will dive into compelling conversations with a diverse array of FDA-focused professionals, who shed light on the developments shaping the future of FDA. Visit to subscribe today! Music by from .
info_outlineIn this episode, Shelly and Wayne chat with Neil O’Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani LLP, and John Swayer, President of Realistic Quality Solutions, LLC. You’ll hear their thoughts on the top priorities in medical device regulation for the next FDA Commissioner and their insights on laboratory-developed tests, the transition to ISO 13485, cybersecurity guidance and regulation, and digital health product regulation.
In our headlines segment, Shelly and Wayne delve into these major developments:
Pharma: FDA Issues Draft Guidance on Accelerated Approval of Drugs for Serious Conditions
Devices: FDA Publishes Report on Risks and Benefits to Health of Non-Device Software Functions
Food: USDA and FDA Announce Joint Request for Info on Food Date Labeling
Cosmetics: FDA Updates Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products
In our Resource Links segment, we listed key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.
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Music by Dvir Silver from Pixabay.