The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Microbiology Data for Systemic Antibacterial Drugs--Development, Analysis, and Presentation.'' The purpose of this guidance is to assist sponsors in the development, analysis, and presentation of microbiology data during antibacterial drug development. This guidance finalizes the draft guidance of the same name issued on September 17, 2009.
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Microbiology Data for Systemic Antibacterial Drugs-Development, Analysis, and Presentation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Microbiology Data for Systemic Antibacterial Drugs--Develop...
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81 FR 58941
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“Microbiology Data for Systemic Antibacterial Drugs-Development, Analysis, and Presentation; Guidance for Industry; Availability,” thefederalregister.org (August 26, 2016), https://thefederalregister.org/documents/2016-20473/microbiology-data-for-systemic-antibacterial-drugs-development-analysis-and-presentation-guidance-for-industry-availabil.