US FDA explains drug label comprehension studies
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration has issued guidance explaining how sponsors of non-prescription medicines should design label comprehension studies for assessing the extent to which consumers understand the information on a drug label1,2.The guidance deals with the general concepts that should be considered in the design and conduct of such studies.
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Global Pharma Guidance Tracker – March 2024
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