FDA Announces Availability of the Guidance, “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format”

FDA Announces Availability of the Guidance, “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format” 

On December 5, 2016, the U.S. Food and Drug Administration (FDA) announced the availability of the guidance for industry entitled “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.” FDA finalized the guidance after carefully reviewing comments received on the 2014 revised draft guidance entitled “Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products--Considerations, Content, and Format” and in light of the Agency’s increased regulatory experience implementing the Physician Labeling Rule and FDA’s labeling and communication initiatives to ensure consistency and clarity.

The guidance describes the recommended information to include in the CLINICAL PHARMACOLOGY section of labeling (also known as the prescribing information or PI) that pertains to the safe and effective use of human prescription drug and biological products. Optimal pharmacotherapy is driven by an understanding of a drug’s clinical pharmacology and the clinical context in which the drug will be used.  

This guidance 

• is intended to ensure consistency, as appropriate, in labeling of the CLINICAL PHARMACOLOGY section for all prescription drug products approved by the FDA
• provides clarity on the information that should be included in section 12 CLINICAL PHARMACOLOGY of the prescription drug labeling 
• provides a general framework and set of recommendations that should be adapted to specific drugs and their conditions of use
• emphasizes the importance of providing variability measures related to pharmacokinetic measures and parameters, pharmacodynamic measures, and other clinical pharmacology study results
• emphasizes use of a format that best accommodates the breadth and complexity of the clinical pharmacology presented (i.e., text, tables, figures)
• provides guidance on the inclusion of clinical recommendations based on clinical pharmacology findings in other sections of the labeling 
• outlines the use of subsections, headings, and subheadings to provide organization for the CLINICAL PHARMACOLOGY section in labeling

Not all of the information identified in this guidance for inclusion in the CLINICAL PHARMACOLOGY section of product labeling will be applicable for every drug.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

Instructions for submitting either electronic or written comments on Agency guidances at any time may be found in the federal register notice for this guidance (http://go.usa.gov/x8mgK).

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The “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format” guidance is available at http://go.usa.gov/x8P89. Please refer to the guidance for more details.

We always welcome your thoughts regarding the format, content, and utility of information you receive via this burst email initiative. Comments may be sent via email to ocp@fda.hhs.gov.

This Clinical Pharmacology Corner Bulletin was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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FDA/Center for Drug Evaluation and Research (CDER)
Office of Translational Sciences
Office of Clinical Pharmacology
Email: ocp@fda.hhs.gov