Federal Register Notice: FDA is making available a draft guidance for industry, Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices. The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that the agency identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available. The document describes procedures and responsibilities for updating information on susceptibility test interpretive criteria, susceptibility test methods, and quality control parameters in the labeling for systemic antibacterial drug products for human use. It also describes procedures for making corresponding changes to susceptibility test interpretive criteria for antimicrobial susceptibility testing devices. To download this guidance, click here. To view this notice, click here.