2003, FDA Approval and Testimonials - Drug Discovery Digest

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2003

FDA Approval

Testimonials

Not the Best Wisconsin Law Decision We’ve Ever Seen

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.

Testimonials

Testimonials Production FDA Approval FDA

The FDA and Feasible Alternative Designs

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.

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Not the Best Wisconsin Law Decision We’ve Ever Seen

The FDA and Feasible Alternative Designs

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