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2004

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

JANUARY 12, 2025

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

Clinic Relationship Provider IT

Keynote: Finding your bliss—beating physician “burnout”

Pamela Wible MD

JUNE 19, 2025

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. In order to heal her patients she first had to heal her ailing profession.

Clinic

Clinic Nurse Practitioner IT Medical

Primary Care Digest

FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

Keynote: Finding your bliss—beating physician “burnout”

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