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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance. Moreover, it was also interesting to see how FDA discussed the concept of unmet medical need in the limited fashion that it did in this new guidance.

Clinic 64
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Keynote: Finding your bliss—beating physician “burnout”

Pamela Wible MD

Published 2/5/19, updated 6/19/25) Rowdiest audience ever (at a medical conference at least). It’s now so common that more than half of all doctors report symptoms, with medical students , residents , and even senior clinicians feeling pushed to the brink. Among medical trainees suicide is the number one cause of death today.

Clinic 246