FDA Law

JANUARY 12, 2025

FDAs Overview of When Accelerated Approval is Appropriate The new draft guidance explains, that there are two circumstances in which the accelerated approval authority would most clearly apply: (1) when the course of the disease is long or (2) the clinical event that is relevant for demonstrating benefit occurs infrequently.

Clinic 64

Clinic Relationship Provider IT 64

GeriPal

MARCH 6, 2025

By the time he got into us, the tumor grew, he had experienced, he was experiencing significant pain and so trauma, informed care and building a relationship with him was such a big part of the care. And this is really traumatic event for his street family and the street community that he knew. Government is not the 51st state.

Healthcare 100

Healthcare IT Community Illness 100

GeriPal

JUNE 26, 2025

Those disruptive events or shocks often portend a major decline in function from which people with dementia never fully recover. Today we talk about disruptive events, or health and wealth shocks. Wait, so one key message is that social health is linked to physical and cognitive health?!? What’s a disruptive event?

Illness 93

Illness Hospital IT Patient-Centered 93

GeriPal

SEPTEMBER 5, 2024

So in some ways, it was an iatrogenic event. There was also a second event in that the pressures chosen weren’t the ideal ones. I mean, obviously nobody fed her the pill with the intention of choking her, but it wasn’t like suddenly she had another event out of the blue because she had a bad heart. Eric 46:49 Yeah.

Patients 98

Patients IT Patient-Centered Hospital 98

GeriPal

DECEMBER 7, 2023

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. We are already seeing effects and they’re pretty much every body system.

Healthcare 129

Healthcare IT Education Community 129