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GUIDANCE DOCUMENT

Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs December 2017

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2017-N-5925
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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).

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All written comments should be identified with this document's docket number: FDA-2017-N-5925.

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