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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

Background on Accelerated Approval The key concept, an ingenuity of FDA itself that has been around since the beginning of accelerated approval, is to allow earlier access to a promising therapy for a serious condition with an unmet medical need based on an endpoint that is reasonably likely to predict clinical benefit.

Clinic 64
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New Technologies and 3D Imaging — “The Virtual Microscope”

CDOCS

This entails that I implement products that have been researched with scientific evidence and are proven as clinically viable. I personally invested in a microscope (Global) in 2004. & I pride myself being on the “leading edge” of technology but not the “bleeding edge” of technology.

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PEMPix 2024 Online Case #2: Flight of Passage

PEMBlog

Pulmonology and surgery were consulted during his hospital stay, and he has since had a left lower lobectomy after healing from his pneumonia. Most patients are afebrile by the third day of treatment and clinically improved within two weeks. 2004 Nov;49(4):302-9. PMID: 442005; PMCID: PMC471015. doi: 10.1016/j.jinf.2003.11.013.