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FDA: Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation

21.09.2009
The purpose of this guidance is to inform industry of the Food and Drug Administration’s (FDA’s) current thinking regarding the types of microbiological studies, assessments, and clinical trials needed to support an investigational new drug application (IND) and a new drug application (NDA) for a systemic antibacterial drug product.

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