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

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. 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? Is that right?

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

FDA Law Blog

SEPTEMBER 6, 2021

Though the carve-out seems at odds with FDA’s regulations requiring generic drugs to have the “same labeling” as their RLDs, such regulations specifically provide for differences arising from carved-out, patent-protected method of use. Instead, it was GSK who erred in omitting the post-MI language from the use code.

IT 52

IT Provider ER Insurance 52

GeriPal

SEPTEMBER 14, 2023

2020 Hospital at Home-Plus: A Platform of Facility-Based Care. And we would provide ongoing longitudinal care to them in the home, much like the Mount Sinai Visiting Doctors programs, and other programs like that. And the treatments are different than what hospice might provide in the home setting. Annals of Int Med.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115