Federal Register Notice: FDA is making available a guidance for industry and review staff, Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information. It includes a definition of established pharmacologic class and helps readers to 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 of approved labeling. The guidance finalizes a 5/16/07 draft guidance. To download this guidance, click here. To view this notice, click here.