FDA Law

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

GeriPal

MAY 5, 2022

And one of the parts of that was actually doing physicals for the students and putting them in job placements. Including more hospital utilization or healthcare utilization, maybe cognitive impairment issues. My own work focuses on hospitalization and health utilization over time. I don’t see myself in that world.”

IT 102

IT Screening Hospital Clinic 102

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. As we age, our body’s capacity to adapt to things becomes a little more challenge. They can save a lot of money.

Healthcare 128

Healthcare IT Education Community 128