Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format." The recommendations in the draft guidance are intended to help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.