FDA publishes draft guidance on developing antibacterials

FDA published draft guidance on how to streamline clinical trials of therapies for serious bacterial diseases in patients with unmet medical need, including pathogen-focused antibacterials that have a narrow spectrum of activity or are only active against a single genus and species of bacteria. The guidances provides a series of questions and answers detailing suggestions on ways to speed up clinical development of such antibacterials, including cutting enrollment size and duration of randomization. Comments are due Sept. 30. ...