SQA

FEBRUARY 15, 2023

” The reason: The existing document of the EU GMP Guideline dates back to 2011 and no longer corresponds to the state of the art in various areas or does not consider increasingly important new technologies for the GMP field, according to the EMA. ” The requirements for providers (e.g.,

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. Plaintiff knew about it, too, since he signed an informed consent document mentioning it.

FDA 105

FDA US Department of Health and Human Services COVID-19 COVID-19 Vaccine 105

Drug & Device Law

DECEMBER 21, 2023

Allegedly, consumers deprived of efficacy (not risk) information had their informed consent rights infringed, which in the case of persons without the genetic difference, meant that they were spared the expense of undergoing negative genetic testing. The penalty did not hold up, but the duty did.

FDA 52

FDA Fraud Informed Consent 52

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. 2011 WL 8879258 (Mag. 20, 2011), adopted , 2011 WL 8879259 (W.D. 9, 2011); Williams v. 2011). . . . [U]nlike 341 (2001).

Informed Consent 59

Informed Consent FDA Doctors 59

Drug & Device Law

JUNE 6, 2022

2011) (no causation where “at the time of her deposition ? the very same illness for which she treated Plaintiff”); In re Trasylol Products Liability Litigation , 2011 WL 2117257, at *5 (S.D. May 23, 2011) (no causation where prescriber “testified. . . GlaxoSmithKline , 2011 WL 6001864, at *3 (D. 2d 1254, 1261 (S.D.

FDA 59

FDA Doctors Malpractice Informed Consent 59

Drug & Device Law

MAY 30, 2022

Because the “additional information” offered by plaintiff would “not [] have any impact on [the prescriber’s] decision to prescribe,” the plaintiff “fail[ed] to raise a genuine issue of material fact on causation.” Johnson & Johnson , 2011 WL 3876997 at *11 (S.D. 31, 2011), aff’d , 483 Fed. 909 (5th Cir.

Doctors 59

Doctors Licensing Informed Consent Hospitals 59