Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases." The purpose of the guidance is to assist sponsors in the development of new antibacterial drugs to treat serious bacterial diseases in patients with an unmet medical need, including patients who have a serious bacterial disease for which effective antibacterial drugs are limited or lacking. This guidance finalizes the draft guidance of the same name issued July 2, 2013.