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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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
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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. I was suicidal myself as a physician and I survived that in 2004. I give you Dr. Pamela Wible.

Clinic 246