FDA Law

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. FDA published a June 2019 guidance , which stated that manufacturers would not need to perform long-term studies or submit long-term data in PMTAs. In Wages and White Lion Investments (DBA Triton Distribution) v.

Manufacturing 115

Manufacturing IT Provider ER 115

GeriPal

MARCH 24, 2023

Full disclosure, I talked with Ava Kofman a bunch while she was preparing that article, and I thought based on my professional experience working in hospice, things that I had seen, that she raised a lot of issues that I had personally encountered in my clinical experience. Eric: The three point difference in this, what? Eric: Okay.

IT 113

IT Provider Patients Families 113

GeriPal

DECEMBER 5, 2024

It’s that mixture of intimacy and vulnerability, of shared clinical experiences, that fosters a sense of belonging. We definitely draw on the sciences, on biomedical science, on clinical trials, on pharmaceutical design and all sorts of things like that. It was late on a Friday afternoon in December 2019. Ricky 11:23 Yeah.

IT 107

IT Community Patients Families 107

GeriPal

APRIL 18, 2024

Alex: In 2019 … You wrote two viewpoints about AI recently in JAMA, relatively recently. I guess, 2019, and then, one again about last month or so. And you say, “Okay, that’s fine, but can it really … What about a real live clinical situation?” That is the first clinical use case. Eric: Yeah.

IT 139

IT Electronics Patients Healthcare 139