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GUIDANCE DOCUMENT

Format and Content of the Microbiology Section of an Application* Guidance for Industry January 1990

Final

Format and Content of the Microbiology Section of an Application*

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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

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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.