GUIDANCE DOCUMENT
Label Comprehension Studies for Nonprescription Drug Products August 2010
- Docket Number:
- FDA-2009-D-0181
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and Research
The Food and Drug Administration (FDA) sometimes requires sponsors to conduct label comprehension studies that are designed to evaluate proposed nonprescription drug product labeling. This guidance is intended to provide recommendations to industry on conducting label comprehension studies. A label comprehension study assesses the extent to which consumers
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