Draft Guidance for Industry and Review Staff on Labeling for Human Prescription Drugs-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled "Labeling for Human Prescription Drugs--Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information." This guidance is intended to help applicants and the review staff in the Center for Drug Evaluation and Research (CDER) at FDA determine when a drug belongs to an established pharmacologic class as well as how to select the appropriate word or phrase (term) that describes the pharmacologic class for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling.