Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval." The purpose of this guidance is to provide information on FDA's current thinking regarding appropriate use of noninferiority (NI) clinical trial designs to evaluate antibacterial drug products. The Agency's thinking in this area has evolved in recent years in response to a number of public discussions on the use of active-controlled trials designed to show NI as the basis for approval of antibacterial drug products. This guidance finalizes the draft guidance published in the Federal Register of October 15, 2007.