FDA issues final guidance for antibacterial streamlined program

FDA issued final guidance for companies developing new antibacterial drugs. The guidance outlines a streamlined development program for products targeting serious bacterial diseases in patients with an unmet medical need, including serious diseases for which effective antibacterial drugs are limited or lacking.

FDA said candidates for a streamlined program include products with a new mechanism of action, an added inhibitor that neutralizes resistance, or an alteration in molecule structure that limits resistance. However, the agency said products that have "slightly greater potency" should be developed under a traditional program. Pathogen-specific products could also be considered for the program where the trial would enroll patients based on the bacterial species causing the infection and not necessarily the site of infection...