A guidance to help applicants and the review staff in the FDA's Center for Drug Evaluation and Research determine when a drug belongs to an established pharmacologic class, as well as how to select the appropriate word, phrase, or term that describes the pharmacologic class for inclusion in approved prescription drug labeling was issued by the FDA. Titled “Labeling for Human Prescription Drugs—Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information,” the guidance applies only to the use of the pharmacologic class in the Indications and Usage section of Highlights of Prescribing Information labels. The guidance finalizes a draft document of the same title announced in the Federal Registerof May 16, 2007.
SOURCE: FDA Notice
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