Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices

New Guidance. The Food and Drug Administration announced in a Federal Register notice of July 2, 2009, the availability of a guidance for industry entitled ‘‘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) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available. This guidance describes how FDA will comply with the FDAAA requirement and procedures for application holders to update the labeling of antibacterial drug products and antimicrobial susceptibility testing.
http://edocket.access.gpo.gov/2009/pdf/E9-15682.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM169359.pdf