Best Practices to Comply with Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products

• By: Staff Editor
• Date: December 15, 2011

The FDA has published a guidance document detailing which studies should be included in the clinical studies section of prescription drug labeling, how individual studies should be described, and what data should be presented. The guidance aims at making the clinical section labeling more useful, helping promote consistency in content and format across various drug product classes and indications.

This article describes the best practices to comply with the recommendations in this guidance.