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Hospital-Acquired Pneumonia Is Life Or Death, FDA Says; Recommends All-Cause Mortality As Sole Primary Endpoint

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Rigorous enrollment criteria and strict endpoints characterize FDA's new draft guidance on developing drugs for hospital-acquired and ventilator-associated bacterial pneumonia, even compared with the agency's recent draft guidance on developing drugs for community-acquired bacterial pneumonia.

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