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GUIDANCE DOCUMENT

Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices Guidance for Industry and Food and Drug Administration Staff February 2019

Final
Docket Number:
FDA-2016-D-2561
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of these products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-2561.