Abstract: Objective To study the evaluation work of FDA updated fluoroquinolone label and to provide reference for the post-marketing evaluation of risk-benefit of drug and better management in China. Methods This article introduced the background, contents and results of the evaluation of the fluoroquinolones to analyze the regulatory thinking and methods of drug management in the United States. Results This work is not only a comprehensive evaluation of the safety of fluoroquinolones, but also carries out risk-benefit assessment for three indications, which is of great significance for the safety of fluoroquinolones. Conclusion Paying attention to the means of foreign advanced drug management can provide ideas and reference for the post-marketing evaluation of drugs in China.

Key words: fluoroquinolone, label, review