FDA Law Blog

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. FDA complied with that order, later extended the deadline because of COVID, and eventually settled on a PMTA deadline of September 9, 2020. In Wages and White Lion Investments (DBA Triton Distribution) v.

Manufacturing 115

Manufacturing IT Provider ER 115

GeriPal

APRIL 10, 2025

You know, most, most ERs admit, you know, far fewer than 50% of their patients. They go to observation and go home or just get discharged straight from the ER? Yeah, that’s a more complicated story. But yeah, it’s complicated. So I’m going to be called every 20 minutes to go to the ER.

Patient-Centered 78

Patient-Centered IT Hospital Patients 78

FDA Law Blog

SEPTEMBER 6, 2021

Teva submitted an ANDA in 2002, and after some complicated regulatory history, ultimately carved-out the congestive heart failure indication by way of a section viii statement. Teva argued that the October 2020 decision, due in part to a lack of clarity, essentially imposed liability on any ANDA filer relying on a carve-out.

IT 52

IT Provider ER Insurance 52

GeriPal

SEPTEMBER 14, 2023

2020 Hospital at Home-Plus: A Platform of Facility-Based Care. The pneumonia could get treated, but I think geriatricians, actually, were well aware of iatrogenic complications of care and quality gaps, even well before the IOM reports of the late 1990s and the like. That started in November of 2020. Annals of Int Med.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115