Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. Informed consent includes the following basic elements: Description of clinical investigation.

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Informed Consent FDA Compliance Regulatory Compliance 40

MedTrainer

OCTOBER 4, 2023

Corporate compliance training helps healthcare organizations balance the need to provide top-notch care with adhering to a plethora of regulations. What Is Corporate Compliance Training? What Is the Difference Between Corporate Compliance Training and Regulatory Compliance Training?

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Drug & Device Law

DECEMBER 29, 2023

This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. Plaintiff knew about it, too, since he signed an informed consent document mentioning it. If any of these are your cases, the Blog congratulates you. And lost again on appeal in Cates.

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

Drug & Device Law

APRIL 21, 2023

That would be especially true in states where regulatory compliance is a defense or partial defense. These paradigms are difficult to apply to healthcare providers, who operate under a different warnings regime that focused on informed consent. Try instructing a jury on how that ought to work.

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