Prior Antibiotic Use A Necessary Confounder In Pneumonia Trials, Panel Says
Executive Summary
FDA panel chose practicality over preference in suggesting that trials for hospital- and ventilator-acquired bacterial pneumonia can enroll patients who have previously received antibiotics.
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The Anti-Infective Drugs Advisory Committee's failure to agree on a preferred approval pathway for antibiotics to treat community-acquired bacterial pneumonia opens the door for FDA to offer several options to industry.