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Recent Episodes
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What’s Coming in Device, Cybersecurity, and Digital Health Product Regulation
Hear from our two guests 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, and more. Listen ⇢
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Key Pharmaceutical Regulation Issues for the New Administration
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. Listen ⇢
FDA Watch Podcast 