- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance is intended to provide recommendations to industry involved in developing and conducting self-selection studies to support an application for nonprescription drug products. A self-selection study assesses the ability of consumers to apply drug labeling information to their personal health situation to make correct decisions about whether or not it is appropriate for them to use a drug product.
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-2011-D-0620.