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PEMPix 2024 Online Case #2: Flight of Passage

PEMBlog

He had easy work of breathing, and physical exam was only notable for decreased breath sounds over the left lower lobe. Pulmonology and surgery were consulted during his hospital stay, and he has since had a left lower lobectomy after healing from his pneumonia. 2004 Nov;49(4):302-9. He was saturating 100% on room air.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

Lastly, the reforms enacted by FDORA required that FDA publish guidance on early consultation with FDA to identify novel surrogate or intermediate clinical endpoints, use of novel trials designs for postapproval studies, the expedited withdrawal procedures, and considerations related to the use of surrogate and intermediate clinical endpoints.

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