How does a products brief summary differ from its approved labeling?
The brief summary is generally shorter — sometimes significantly so. The brief summary typically includes only the risk-related sections of the product’s labeling. This is because the advertising text itself generally meets the requirement for including effectiveness information by giving the product’s indication (i.e., what it is used for), and any limitations concerning how and when the product should be used. In contrast, product labeling includes non-risk-related information, including all effectiveness information (sometimes even about the clinical studies used as the basis for product approval), how it should be taken (dosage information), how the drug product is supplied (e.g., the quantity of drug in each pill), and information about how the product works in people’s bodies.
