Flexible 'Menu' Of Antibacterial Development Options Suggested By US FDA Panel

19 Apr 2017

• By Michael Cipriano

FDA should consider allowing sponsors in challenging area of single species antibacterials more flexibility in study designs, advisory committee suggests, despite disagreement over approaches such as animal models and non-inferiority trials.

Antibiotic resistant bacteria closeup biofilm

FDA should consider allowing sponsors of treatments targeting a single species of bacteria to select from, and possibly combine, studies from a menu of options to evaluate safety and effectiveness, FDA's Antimicrobial Drugs Advisory Committee suggested in a recent discussion.

The agency did not pose voting questions to the panel at its April 13 meeting. But the discussion indicated general...