Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products--Content and Format." This guidance is intended to assist applicants in writing the Indications and Usage section of labeling. The recommendations in this draft guidance are intended to help ensure that the labeling is clear, concise, useful, and informative and, to the extent possible, consistent in content and format within and across drug and therapeutic classes.