Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability

Resumen

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Self-Selection Studies for Nonprescription Drug Products." 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. This guidance finalizes the draft guidance issued on September 19, 2011.