FDA Guidance on Label Comprehension Studies for Over-the-Counter (OTC) Drugs
This post was written by Paul Sheives and Areta Kupchyk.
FDA has issued a guidance document entitled “Label Comprehension Studies for Nonprescription Drug Products“ to provide recommendations to industry on conducting label comprehension studies for OTC drug products. The guidance discusses situations where FDA might require a label comprehension study, and provides guidance on the design and conduct of such studies, including the preparation of final reports and various statistical issues inherent to these studies.
