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Newsletter - April 20, 2023

Why is FDA Quiet About the Off-Label Promotion of Ozempic? Ozempic Vs Viagra

The media frenzy driven by social media posts describing the off-label use of Ozempic and similar drugs for weight loss has seemingly caught the FDA off-guard. This is a classic case of where off-label promotion of a product by sources independent of the manufacturers has yielded excessive riches for the manufacturers. Read More

FDA’s Warning Letter Highlights Need for Pre-Approval of Device Modifications
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Medical device manufacturers need to re-access if their device’s FDA approval or clearance is still valid upon making modifications to the device. Not doing a proper assessment could lead to FDA deeming the device illegally marketed. This hard lesson was learnt by Abbott’s Canadian unit selling a diagnostic...Read More

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