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# Antibiotic Susceptibility Test Guidance
- URL: https://www.fdaweb.com/antibiotic-susceptibility-test-guidance/
- Published: 2017-12-13T12:00:00.000Z
- Updated: 2026-09-14T23:08:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140333

FDA has published a guidance, *Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs*, with recommendations on fulfilling new labeling requirements for susceptibility test interpretive criteria for prescription systemic antibacterial and antifungal drugs as established by the 21st Century Cures Act. Included are the agency’s recommendations on **(1)** how to make the labeling changes for antimicrobial drugs with NDAs or ANDAs; **(2)** language to remove from the labeling of such drugs; and **(3)** labeling language to use for all antimicrobial drugs to reference FDA’s Susceptibility Test Interpretive Criteria Web page.

The guidance says that at least every six months FDA will publish on the Interpretive Criteria Web page a notice that **(1)** recognizes new or updated susceptibility test interpretive criteria standards or parts of standards; **(2)** withdraws recognition of susceptibility test interpretive criteria standards or parts of standards; and **(3)** makes any other necessary updates to the lists published on the Interpretive Criteria Web page. In addition, FDA says it will update the Web page with susceptibility test interpretive criteria upon approval of an NDA for an antimicrobial drug, as appropriate.