2003 FDA Approval Testimonials 
Drug & Device Law
FEBRUARY 20, 2023
But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.
Drug & Device Law
APRIL 18, 2022
The surgeon’s testimony supported two grounds for non-causation: lack of reliance, and that a warning would not have changed how the prescription product was used. at *3 – which means, as we’ve discussed before , a manufacturer cannot include warnings about such off-label uses absent specific FDA approval. 3d 203 (5th Cir.
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