Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40

Drug & Device Law

JANUARY 15, 2024

and [defendants’] response thereto, the trial court did not abuse its discretion by disallowing the evidence. In my view, the complicated legal issue presented in this appeal is unfortunately not resolvable because of the undeveloped evidentiary record and undirected advocacy in the trial court. Medtronic, Inc. , Ethicon, Inc. ,

Compliance 52

Compliance Government FDA Compliance Production 52

Drug & Device Law

JUNE 1, 2023

We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “ Frye ” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this: Rule 702. E.g. , Walsh v. BASF Corp. , 3d 446, 461 (Pa.

Testimonials 59

Testimonials Trials Science Government 59

Drug & Device Law

APRIL 18, 2022

The trial court granted summary judgment based on evidence that the implanting surgeon “would have used the clips in the surgery even if he had received such a warning” and thus plaintiff “could not prove the cause element of his claims.” Wyeth Pharmaceuticals , 471 F. 2d 739, 747 (E.D. 3d 203 (5th Cir. 2008); Herzog v.

Testimonials 59

Testimonials Production FDA Approval FDA 59

Drug & Device Law

FEBRUARY 20, 2023

2006), app. The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. 2d 839, 851 (N.Y. 2d 506 (N.Y.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. Confident learned intermediaries stand by their medical decisions. caused anything. 3d 87, 95 (Tex.

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Testimonials Production Pharmaceuticals Treatment 59