HIT Consultant
JANUARY 16, 2024
Director, Product & Strategy, Patient Consent, IQVIA Technologies The clinical trials landscape continues to evolve and with it, an exponential growth in the adoption of electronic informed consent (eConsent) solutions. These solutions deliver a myriad of benefits for trial sponsors, sites and patients.
Bill of Health
MARCH 9, 2022
He has contributed to public psychedelic research and harm reduction efforts through a variety of organizations and outlets since 2009. Lily Kay Ross, MDiv, PhD has been taking a feminist approach to theorizing psychedelic ethics since 2009, especially with regard to sexual misconduct, abuses of power, and gendered violence.
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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.
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.
Drug & Device Law
SEPTEMBER 9, 2022
Larkin did not discuss the standard for proximate causation or suggest, as Thacker implies, that informed consent is part of the inquiry. Pfizer, Inc. , 3d 758, 769-70 (Ky. 2004), where the Kentucky Supreme Court adopted the learned intermediary doctrine. The second was the decision below.
Drug & Device Law
AUGUST 22, 2022
This time, plaintiff pleaded “1) violation of [defendant’s] premarket approval; 2) breach of implied warranty; and 3) lack of informed consent (failure to warn).” Id. 2009 WL 3294873 (D. 14, 2009) (all plaintiffs having all claims dismissed as a matter of law). Mentor Worldwide, LLC , 2019 WL 6766574 (M.D. 341 (2001).
Drug & Device Law
JUNE 6, 2022
2009), reversed a plaintiff’s verdict for entry of judgment n.o.v. years after [plaintiff] developed [the complained-of condition] and [prescriber] continues to prescribe [the drug] to his patients”); In re Zyprexa Products Liability Litigation , 2009 WL 5062109, at *14-15 (E.D.N.Y. July 8, 2009) (applying California law); Nix v.
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