Drug & Device Law

DECEMBER 21, 2023

23, 2010) ( here ), can supersede our list, so far they’ve been thankfully uncommon. That’s significant because the labels for over 500 drugs already have such information, under a voluntary FDA program. Holley also allowed a “pre-approval” warning claim to escape preemption, largely on the same rationale. Novartis , 407 P.3d

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FDA Approval FDA Drugs Production 52

Drug & Device Law

JULY 24, 2023

The class period is between 1999 and 2010. This time-tested type of evidence is mostly absent from the analysis in PATDC82 II – as in Neurontin , the only actual prescriber testimony belied plaintiffs’ position. at *3 (footnote omitted). We searched PATDC82 II for the word “generic” – it does not appear.

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Drug & Device Law

MARCH 16, 2023

In two of these cases, our client won summary judgment at the trial court level and an appellate court ended up creating a new cause of action to accommodate the plaintiff’s theory (and lack of helpful testimony from the prescribing physician). 2010) (Ohio law), and the Pennsylvania Supreme Court in Lance v. Wyeth , 619 F.3d

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FDA Approval FDA Testimonials Production 59

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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FDA FDA Approval Testimonials Vaccine 59