Agency IQ

JUNE 17, 2024

In unanimous decision, Supreme Court solves FDA’s ‘standing’ issue Two lower courts had articulated a Rube Goldberg-esque theory of “standing” – the right of a person or organization to sue another entity – based on the idea that doctors not prescribing mifepristone or treating patients who had taken it had experienced economic harms.

FDA 40

FDA Doctors Testimonials Regulations 40

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. Further, “adequacy” is an objective standard, that neither a plaintiff’s self-interested testimony nor equivocal health care provider testimony can touch.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

JULY 24, 2023

the relationship between [plaintiff] and its pharmacy benefit manager. . . Apparently, massive loss of evidence was merely a “usual and customary service” of pharmacy benefit mangers nationwide. According to Plaintiffs’ expert. . ., is typical of such relationships in the United States, and it includes usual and customary services.

Testimonials 52

Testimonials Pharmacy FDA Doctors 52