FDA Indicates Flexibility On Evidence To Support Efficacy In Pneumonia
This article was originally published in The Pink Sheet Daily
The agency will seek advisory panel input Nov. 3-4 on options for facilitating trials in community-, hospital- and ventilator-acquired pneumonia.
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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.
One Trial Plus Supportive Evidence Is Enough For Hospital-, Ventilator-Acquired Pneumonia Indication, Panel Says
Anti-Infective Drugs Advisory Committee members viewed one-trial as practical means of gaining efficacy data.