FDA panel to discuss antibiotic product labeling

FDA's Anti-Infective Drugs Advisory Committee will meet on Oct. 17 to discuss the interpretive criteria for susceptibility for systemic antibiotics and for dosing recommendations in product labeling. The committee also will discuss revising dosing recommendations based on pharmacokinetic data as well as clinical safety and efficacy data. Susceptibility breakpoints define the concentration/dose of the antibiotic where the bacteria remain susceptible to treatment and where they develop resistance. ...