Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format

Issue Date: December 5, 2016
Issued by: Center for Drug Evaluation and Research
Topic(s): Labeling
Status: Final

Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format

This guidance is intended to assist applicants in preparing the CLINICAL PHARMACOLOGY section of prescription drug labeling (henceforth referred to as labeling) to meet regulatory requirements and ensure appropriate consistency in the format and content of this section for all prescription drugs approved by FDA.

Download the Guidance Document