FDA Releases Draft Guidance for Updating Labeling of Antibacterial Drugs and Devices

Summary

The Food and Drug Administration (FDA) has announced the availability of a draft guidance outlining procedures for updating labeling of systemic antibacterial drug products and antimicrobial susceptibility testing devices to comply with the Food and Drug Administration Amendments Act of 2007 (FDAAA). The draft guidance aims to inform industry on how to identify and update susceptibility test interpretive criteria, methods, and quality control parameters in drug product labeling.