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What is Special about September 24, 2023 for the UDI System?

FDA Law

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. So, what is special about September 24, 2023? Most of the compliance dates have been passed. Emphasis added.)

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Jennifer Newberger Returns to HPM as a Director After Stints with Apple, Abbott Laboratories, and Cognito Therapeutics

FDA Law

Jennifer’s combination of experiences as in-house counsel for both large and start-up companies as well as outside counsel provides clients invaluable expertise and problem-solving skills. She also specializes in medical device software and digital health.

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The Best and Worst Cooking Oils for Managing Cholesterol

Imperial Center Family Medicine

Limiting these cholesterol-raising oils is just as important as utilizing healthier options in your cooking. Save this tropical oil for special occasions versus everyday cooking when managing cholesterol through diet. Our compassionate physicians provide complete cholesterol screenings and treatment plans customized to your needs.

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Skinny Label and Induced Infringement: The Saga Continues

FDA Law

Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.” Whether the Court takes up Teva v. GSK is still up in the air.