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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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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Compliance Regulatory Compliance ADA Informed Consent 52

Drug & Device Law

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Plaintiffs’ own litigation strategy thus opened the door to compliance evidence.

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

Drug & Device Law

APRIL 21, 2023

Heck, Bexis and our colleague Matthew Jacobson even wrote a law review article on the topic a few years back. That would be especially true in states where regulatory compliance is a defense or partial defense. So maybe the manufacturer’s duty to warn and the physician’s duty to obtain informed consent merge.

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Informed Consent Malpractice FDA Regulatory Compliance 59