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GUIDANCE DOCUMENT

Clinical Development and Labeling of Anti-Infective Drug Products February 2001

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

Changing or unclear interpretations of clinical trail data needed to demonstrate the effectiveness and safety of anitmicrobial drug products have at times lead to confusion and frustration on the part of both applicants and Division of Anti-Infective Drug Products reviewers.


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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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