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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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

Informed Consent 40

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.

FDA 105

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

Informed Consent 59

Informed Consent Malpractice FDA Regulatory Compliance 59