Facilitating Antibacterial Drug Development for Patients With Unmet Need and Developing Antibacterial Drugs That Target a Single Species Media; Public Workshop

The Food and Drug Administration (FDA) is announcing a public workshop regarding antibacterial drug development for patients with unmet need and developing antibacterial drugs that target a single species. FDA is interested in discussing the scientific challenges pertaining to such development programs, including enrollment challenges, clinical trial designs, and trial population. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. government Agencies, public health organizations, academic experts, and industry on various aspects of drug development for new antibacterial drugs for patients with unmet need and new antibacterial drugs that target a single species. The input from this public workshop will also help in developing topics for future discussion.