Remove 2004 Remove IT Remove Patient-Centered Remove Physicals
article thumbnail

FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Whether a surrogate or intermediate clinical endpoint (ICE), the endpoint to support accelerated approval is one that can be assessed more rapidly than the ultimate clinical benefit; this is what enables earlier patient access than would be possible while generating the evidence to support a traditional approval, which is typically infeasible.

Clinic 64
article thumbnail

Keynote: Finding your bliss—beating physician “burnout”

Pamela Wible MD

In order to heal her patients she first had to heal her ailing profession. And this is a medical system that needs to be disrupted because our medical system (as you know) is endangering the lives of patients right now—and physicians. But is it really burnout—or something more serious? I give you Dr. Pamela Wible. To be real.

Clinic 246