A new document from the U.S. Food and Drug Administration (FDA): The guidance describes FDA’s recommendations on (1) how to make these labeling changes for Antimicrobial drugs with approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs), (2) language to remove from the labeling of such drugs, and (3) labeling language to use for all antimicrobial drugs to reference the FDA’s Susceptibility Test Interpretive Criteria web page.
Antimicrobial susceptibility testing is used to determine if certain microorganisms isolated from a patient with an infection are likely to be killed or inhibited by a particular antimicrobial drug. Historically, susceptibility test interpretive criteria have been contained in the Microbiology subsection of antimicrobial drug labeling. There have been significant challenges associated with ensuring that this information is up to date in antimicrobial drug labeling
See FDA
Posted by Dr. Tim Sandle
