Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs

Issue Date: December 13, 2017
Issued by: Center for Drug Evaluation and Research
Topic(s): Labeling
Status: Final

Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs

This guidance provides recommendations on fulfilling the new labeling requirements for susceptibility test interpretive criteria for prescription systemic antibacterial and antifungal drugs as established by section 3044 of the 21st Century Cures Act (Cures Act) (Public Law 114-255).

Download the Guidance Document