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 Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)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

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. And nurses and other healthcare practitioners knew nothing about it. My own work focuses on hospitalization and health utilization over time.

IT 102

IT Screening Hospital Clinic 102

GeriPal

MARCH 2, 2023

Eric: And we have Tasce Bongiovanni, who is an acute care trauma surgeon at UCSF and the San Francisco General Hospital. And for that reason, there was actually an enormous lawsuit, and the manufacturer was fined, now I think 20 years ago, in the millions and millions of dollars for off-label prescribing. Nisha: Thank you so much.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law

JANUARY 18, 2024

Controlled substances that have an accepted medical use are classified in schedules II-V based on their relative potential for abuse and physical and psychological dependence. or a currently accepted medical use with severe restrictions; and The drug’s relative safety or ability to produce physical dependence compared to other drugs.

Medical 69

Medical Physicals IT Healthcare Professional 69

GeriPal

MAY 8, 2025

Vincent’s Hospital in Melbourne, Australia. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? We dedicated team working with cancer and palliative medicine in our hospital. James, welcome to the GeriPal Podcast.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

DECEMBER 7, 2023

And so we do see hospital admissions for heat exposure and certainly cardiovascular and respiratory problems related to air pollution with climate change and also cognitive problems. So the things that Karl mentioned, but also access to healthcare during a disaster or even heat. Why is it up to the healthcare system? Ruth: Yeah.

Healthcare 129

Healthcare IT Education Hospital 129