SQA

APRIL 30, 2021

726/2004, 09 March 2021. 726/2004 , which essentially means duplicate MAAs for products authorized via the centralized procedure. EC Issues Notice on the Handling of Duplicate Marketing Authorization Applications (MAAs) of Pharmaceutical Products under Article 82(1) of Regulation (EC) No. Under Article 82(1) of Regulation (EC) No.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

Bill of Health

AUGUST 29, 2022

2004) (“[T] the fundamental right to an opportunity for an education does not guarantee that a student cannot temporarily forfeit educational services through his own conduct. Comm’n of the States (March 2016), [link] (50 state survey on state constitutional rights to education). However, because Washington, D.C., 3d 868, 874 (Wyo.

COVID-19 Vaccine 130

COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Drug & Device Law

JUNE 6, 2022

2004) (no causation where prescriber “continues to prescribe [similar] medication. . . 8, 2019) (no causation where prescriber “testified that none of the additional risk information. . . 2004); In re Accutane Litigation , 2016 WL 355843, at *8-9 (N.J. 2004 WL 5628157, at *5 (W.D. See Ehlis v. Shire Richwood, Inc. ,

FDA 59

FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

MAY 30, 2022

2004) (another case we discussed in 2008 ), because the plaintiff failed to “produce[] evidence that the risk. . . Being “aware of what he considered a stronger warning,” the implanter nonetheless stated that the defendant’s product “was in his opinion the best option.” Warning causation likewise failed as a matter of law in Motus v.

Doctors 59

Doctors Licensing Informed Consent Hospitals 59

Drug & Device Law

SEPTEMBER 9, 2022

2004), where the Kentucky Supreme Court adopted the learned intermediary doctrine. Larkin did not discuss the standard for proximate causation or suggest, as Thacker implies, that informed consent is part of the inquiry. The first is Larkin v. Pfizer, Inc. , 3d 758, 769-70 (Ky.

Doctors 59

Doctors Informed Consent 59

Drug & Device Law

DECEMBER 9, 2022

And the court agreed, finding that “the undisputed facts reflected that [the doctor] testified she read the IFU, relied on the warnings provided by [the defendant], believed she had a comprehensive informed consent process, and would have passed on a warning about the risk of severe and chronic pain to patients. Pfizer, Inc ,196 F.

Doctors 64

Doctors Fraud Informed Consent 64