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Comments Sought on Antibacterial/Antimicrobial Guidance

04/07/2014

Federal Register Notice: FDA is seeking comments on its Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices. The guidance 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, and also describes procedures for making corresponding changes to susceptibility test interpretive criteria for antimicrobial susceptibility testing devices. Comments should be submitted by 6/6. To view this notice, click here.

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