Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease; Public Workshop; Request for Comments

摘要

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease." The purpose of the public workshop is to discuss the clinical trial design considerations, including endpoints, related to the development of antibacterial drug products for treatment of nontuberculous mycobacterial (NTM) disease.