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

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. 2006), app. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. 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.”

Testimonials 59

Testimonials Doctors Production Laboratories 59