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GUIDANCE DOCUMENT

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

Download the Final Guidance Document
Final
Docket Number:
None found
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.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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 written comments should be identified with this document's docket number: None found.

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