BioCentury
ARTICLE | Politics & Policy

FDA seeking input on antibiotic development

May 31, 2013 1:46 AM UTC

FDA's Antibacterial Drug Development Task Force is seeking comments on antibiotic drug development, including potential new study designs, priorities for guidances and strategies to slow the rate of resistance. The task force is seeking ideas for new study designs and comments on methods it is already considering, including adaptive approaches and accelerated approval using either mortality or a surrogate endpoint likely to predict benefit earlier than irreversible morbidity. The task force, which was formed last September and comprises scientists and clinicians within FDA's Center for Drug Evaluation and Research (CDER), also is seeking comments on areas for potential new guidances, including uncomplicated gonorrhea and diabetic foot infection. Comments are due July 30. ...