Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Label Comprehension Studies for Nonprescription Drug Products." The guidance provides recommendations on the design of label comprehension studies that can be used to assess the extent to which consumers understand the information conveyed by proposed nonprescription drug product labeling. This guidance finalizes the draft guidance published on May 1, 2009.