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

2006) – a precedential holding that the same Pennsylvania rule barring strict liability claims against prescription drugs also applied to prescription medical devices − should not be followed because the plaintiffs in Creazzo were supposedly “pro se.” Sanchez , 716 A.2d Janssen Pharmaceuticals, Inc. , Medtronic, Inc. , 3d 709 (Pa.

Compliance 52

Compliance Government Production FDA Compliance 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

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. Medrano , 28 S.W.3d 2d 141 (Pa.

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

Drug & Device Law

MAY 30, 2022

The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. Given this testimony, the plaintiffs could not “show that stronger manufacturer warnings would have altered the physician’s prescribing conduct.” Plaintiff] has not identified any testimony from [the prescriber] that. . .

Testimonials 59

Testimonials Doctors Production Laboratories 59

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. Wyeth Pharmaceuticals , 471 F. 2006) (rejecting distinction between “a case of no warning as opposed to an inadequate warning”), aff’d , 526 F.3d 2d 739, 747 (E.D.

Testimonials 59

Testimonials Production FDA Approval FDA 59