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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

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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.

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