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Antimicrobial susceptibility test guidance

This article was originally published in The Gray Sheet

Executive Summary

FDA's recently released special controls 1guidance on antimicrobial susceptibility test (AST) systems updates a March 2007 document of the same title. The guidance was first issued in 2000 when the agency down-classified short-term incubation cycle AST systems to class II with special controls. The revised guidance includes additional AST labeling instructions for firms to follow when drug makers update antibiotic labeling on bacterial susceptibility to treatment. In June 2008, FDA issued 2guidance to drug makers calling for annual labeling revisions for systemic antibacterial products

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