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GUIDANCE DOCUMENT

Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format December 2016

Final
Docket Number:
FDA-2009-D-0095
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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.
 


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All written comments should be identified with this document's docket number: FDA-2009-D-0095.