- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter 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.
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:
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.