FDA Eases Clinical Trial Requirements for ABSSSI Drugs in Final Guidance

October 21, 2013
While the FDA generally requires two Phase III trials to support approval of acute bacterial skin and skin structure infection (ABSSSI) drugs, the agency said Wednesday it is willing to consider approval based on a single Phase III study that is supported by additional independent evidence. Sponsors should discuss such supportive evidence with the agency in advance, final guidance on ABSSSI drug development states.
Drug Industry Daily