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PEMPix 2024 Online Case #2: Flight of Passage

PEMBlog

At that point, he was referred to pulmonology who started the patient on albuterol, manual chest physiotherapy, and a steroid inhaler with a plan for a fourth chest x-ray four weeks later. On arrival, the patient was febrile to 38.3C. Bronchopulmonary sequestration Our patient was diagnosed with bronchopulmonary sequestration (BPS).

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

Whether a surrogate or intermediate clinical endpoint (ICE), the endpoint to support accelerated approval is one that can be assessed more rapidly than the ultimate clinical benefit; this is what enables earlier patient access than would be possible while generating the evidence to support a traditional approval, which is typically infeasible.

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