Briefing Summary: US FDA Posts Advisory Committee Materials for Review of the Efficacy and Safety of Fluoroquinolone Antibacterial Drugs – NOV 5, 2015 (AMDAC-DSRM)

The US FDA has posted details, including Company and FDA Briefing Materials, for the Thursday, November 5, 2015 joint meeting of the Antimicrobial Drugs Advisory Committee (AMDAC) and the Drug Safety and Risk Management Advisory Committee (DSRM). The Committees will discuss the risks and benefits of systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease (ABECB-COPD), and uncomplicated urinary tract infections (uUTI) in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.