Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibac

• Date: November 03, 2009
• Source: www.fda.gov

The Food and Drug Administration (FDA) is announcing 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 requirementthat FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug productsand make those findings publicly available. This guidance describes how FDA will comply with the FDAAA requirement and procedures forapplication holders to update thelabeling of antibacterial drug products and antimicrobial susceptibility testing (AST) devices.
 

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