Hall Render

SEPTEMBER 14, 2023

Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

FDA 40

FDA Informed Consent COVID-19 Fraud 40

Hall Render

FEBRUARY 10, 2023

billion since pandemic U.S. leading cause of death is heart disease, Alabama’s matches that Alabama lawmakers put temporary hold on $1 billion contract for prison healthcare New rolling NICU a ‘game changer’ for critical babies in Alabama More than a dozen Alabama hospitals at immediate risk of closing; officials say hospitals suffer $1.5

US Department of Health and Human Services 40

US Department of Health and Human Services COVID-19 Nursing Homes Nurses 40

Drug & Device Law

DECEMBER 29, 2023

2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. 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. Monsanto Co. ,

FDA 105

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