Drug & Device Law

MAY 25, 2023

Another motion reflected Bexis original position (but wasn’t Bexis’ motion), that the Institute should prepare black letter, comments and reporters’ notes for both sides of this issue, similarly to the manner in which the same draft handled the question of patient-oriented versus physician-oriented standards for informed consent.

Informed Consent 59

Informed Consent Malpractice Governance 59

Drug & Device Law

APRIL 8, 2022

2009)] saying that the publication of scientific articles, per se, is protected by the right of free speech and can’t be the basis for a lawsuit. That’s why we’re pleased with the ruling in Informed Consent Action v. The government initially tried to accommodate the antivaxxers. Amersham Health, Inc. ,

Informed Consent 72

Informed Consent Governance 72

Drug & Device Law

FEBRUARY 26, 2024

As much as we like preemption, no basis for preemption exists based with respect to the informed consent requirement of the statute’s provision governing emergency use authorized (“EUA”) products, such as (at the time) COVID-19 vaccines. 555, 573 (2009), and these antivaxxers didn’t come close. Second, the FDCA (21 U.S.C.

COVID-19 52

COVID-19 COVID-19 Vaccine Informed Consent FDA 52