Draft Guidance for Industry on Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases." The purpose of the draft guidance is to assist sponsors in the development of new antibacterial drugs to treat serious bacterial diseases, particularly in areas of unmet need, and new antibacterial drugs that are pathogen-focused (i.e., drugs that have a narrow spectrum of activity or are only active against a single genus or species of bacteria).