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

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The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled "Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format." The recommendations in this guidance are intended to assist applicants in developing the "Patient Counseling Information" section of labeling and to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format. This guidance finalizes the draft guidance issued on September 18, 2013.