2011, Fraud and Informed Consent - Health Care Compliance Brief

Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 21, 2023

The logic of the consumer fraud claim made no sense. 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.

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FDA Fraud Informed Consent

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. 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. Monsanto Co. ,

FDA

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

Health Care Compliance Brief

Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

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