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
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
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
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
