Issue Date: January 1, 1990
Issued by: Center for Drug Evaluation and Research
Topic(s): Microbiology, Pharmaceutical Quality
Status: Final
Format and Content of the Microbiology Section of an Application*: Guidance for Industry
Antimicrobial drugs differ from other classes of drugs in that they are intended to affect microbial, rather than patient, physiology. For this reason, the technical reports of in vivo and in vitro effects on microorganisms are critical for establishing effectiveness.
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