FDA Guidance Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products - Content and Format

• By: www.fda.gov
• Date: December 16, 2011

This guidance is intended to assist applicants in deciding:

(1) what studies should be included in the CLINICAL STUDIES section of prescription drug labeling,

(2) how to describe individual studies, and

(3) how to present study data, including presentation of data in graphs and tables.

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