FDA Law Blog

JANUARY 12, 2025

As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority. First, patients may be exposed to safety risks from a drug that subsequently fails to demonstrate clinical benefit.

Clinic 64

Clinic Relationship Provider IT 64

FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. It was alleged that other employees administered the medication to patients even after observing signs of tampering, although no patients were reported harmed.

Board-Certified 52

Board-Certified Provider Government Management 52

GeriPal

JANUARY 11, 2024

In further contrast to the United States, MAID in Canada is almost entirely administered by a clinician, whereas in the United States patients must self administer. Alex: And we’re delighted to welcome Sonu Gaind, who is a Chief of psychiatry and professor at the Sunnybrook Health Sciences Center at the University of Toronto.

Illness 144

Illness IT Medical Provider 144

FDA Law Blog

NOVEMBER 18, 2024

Incentives to motivate better nutritional choices and increase physical fitness would be welcome. He states, correctly, that PDUFA user fees make up about 75% of the budget for the Center for Drug Evaluation and Research (CDER). In the meantime, this belief was followed for centuries by doctors, to the detriment of countless patients.

Appointment 116

Appointment Vaccination Patient-Centered IT 116