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GUIDANCE DOCUMENT

E10 Choice of Control Group and Related Issues in Clinical Trials May 2001

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1999-D-1874
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended to assist applicants in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment. The guidance also discusses related trial design and conduct issues and describes what trials using each design can demonstrate. This guidance does not address the regulatory requirements of any region.
 

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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: FDA-1999-D-1874.

 
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