Format and Content of the Microbiology Section of an Application* Guidance for Industry January 1990
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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.