Clinical Pharmacology 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 Agency) is announcing the availability of a guidance for industry entitled "Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format." This guidance is one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and form at of labeling for human prescription drug and biological products. The guidance describes the recommended information to include in the CLINICAL PHARMACOLOGY section of labeling that pertains to the safe and effective use of human prescription drug and biological products. This guidance finalizes the 2014 revised draft guidance entitled "Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products--Considerations, Content, and Format."