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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. On August 15, 2023, the U.S.

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Informed Consent FDA Compliance Regulatory Compliance 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. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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

Drug & Device Law

APRIL 21, 2023

The FDA regulates medical devices, including 3d-printed medical devices when made by medical device manufacturers (see here for more information). But point-of-care devices appear to still be a matter of regulatory discussion. That would be especially true in states where regulatory compliance is a defense or partial defense.

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Informed Consent Malpractice FDA Regulatory Compliance 59