Guidance for Industry and Review Staff on Labeling for Human Prescription Drug and Biological Products-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and review staff entitled "Labeling for Human Prescription Drug and Biological Products-- Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information." 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. This guidance finalizes the draft guidance published in the Federal Register on May 16, 2007.