Abstract: Introduce the main contents of FDA amendment act 2007(FDAAA). in this article we review the related files and documents about FDAAA and introduce about the several contents about FDAAA. FDAAA is one of the most important reforms about pharmaceutical industry laws and regulations in US in last 40 years. It touched almost every aspect of process of pharmaceutical management system in US. It is important for pharmaceutical companies to understand the implications of FDAAA. We suggested China should using some experience from FDAAA in our pharmaceutical management work, especially in the drug safety and surveillance.

Key words: amendmentact, drug safety, post-market safety study, Approved Risk Evaluation and Mitigation Strategies(REMS)