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

FDA Law Blog

So, what is special about September 24, 2023? Legacy FDA identification numbers refer to both National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers created using labeler codes previously assigned to device manufacturers by FDA. 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 Blog

She also specializes in medical device software and digital health. With her return to the firm, she can now utilize her recent in-house experience to help HPM’s diverse client base solve complex problems. Jennifer also helps clients with contract matters, regulatory due diligence, and public filings.

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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. Cooking Oils to Limit for High Cholesterol Oils high in saturated and trans fats directly raise LDL cholesterol.

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Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog

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.