NOV 5 AMDAC-DSRM

Background Analysis: US FDA Advisory Committees to Review the Efficacy and Safety of Fluoroquinolone Antibacterial Drugs – NOV 5, 2015 (AMDAC-DSRM)

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

See the SAC Tracker report