Panel Supports Symptoms-Based Endpoint For Community-Acquired Bacterial Pneumonia
This article was originally published in The Pink Sheet Daily
A means of standardizing what are subjective criteria must be developed, the advisory committee stressed to FDA Nov. 3.
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Non-inferiority margins have been a tricky issue as antibiotic sponsors strive to show efficacy without large, lengthy and costly trials.
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.
The agency will seek advisory panel input Nov. 3-4 on options for facilitating trials in community-, hospital- and ventilator-acquired pneumonia.