Drug & Device Law

FEBRUARY 11, 2024

Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v. FDA , 715 F.3d

FDA 59

FDA Production FDA Approval Regulations 59

Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. They excluded bogus expert testimony under Fed. The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

DECEMBER 21, 2023

Bexis’ amicus efforts this year in Mallory obviously came to naught, and we’ve had our own cases on this list before (see, e.g. , 2013-2 and 2021-10 ). That’s significant because the labels for over 500 drugs already have such information, under a voluntary FDA program. A lawyer who never loses doesn’t litigate hard cases.

FDA Approval 52

FDA Approval FDA Drugs Production 52

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). 472 (2013). 2020), helped restore some sanity. Mensing , 564 U.S. Bartlett , 570 U.S.

FDA Approval 59

FDA Approval FDA Testimonials Production 59