Hall Render

OCTOBER 5, 2023

On August 15, 2023, the U.S. 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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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 40

Informed Consent FDA Compliance Regulatory Compliance 40

Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

FDA 105

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

Drug & Device Law

APRIL 21, 2023

84075, 2023 WL 2779206 (Nev. 4, 2023), and while the opinion does not disclose whether the implants were 3D printed, the opinion raises all the same questions. That would be especially true in states where regulatory compliance is a defense or partial defense. The case is Estate of John Cronin v.

Informed Consent 59

Informed Consent Malpractice FDA Regulatory Compliance 59