Guidance for Industry and Review Staff Labeling for Human Prescription Drug and Biological Products

• Date: December 01, 2009
• Source: www.fda.gov

This guidance is intended to provide applicants and review staff with a definition of established pharmacologic class and to help them identify the most appropriate word (term) or phrase that describes the established pharmacologic class for a drug or biological product for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling. Although not specifically required, the pharmacologic class can also appear in other sections of labeling. This guidance only applies to the use of the pharmacologic class in the Indications and Usage section of Highlights

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