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.
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.