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.
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? So we try a pilot.
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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.
GeriPal
JULY 14, 2022
This was the opening paragraph that I wrote in March of 2020 when introducing a podcast we did with Dr. Jim Wright , the medical director at Canterbury Rehabilitation and Healthcare Center in suburban Richmond. That was his literally his life during those spring months of 2020 and it scared the hell out of me. . Darrell: Thank you.
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.
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