FDA法发展对美国生物医药创新的影响

Influence of U.S. FDA laws development on American biomedical innovation

文章介绍了美国食品药品监督管理局(The Food and Drug Administration,FDA)法对药品审查流程与标准的相关规定及其发展历程。然后研究分析了美国专利法与FDA法各自法规及其相互作用如何促进美国生物医药创新,并在此基础上,提出了促进中国生物医药创新的建议。

This article introduces the laws of the U.S.Food and Drug Administration(FDA)on the process and standard of drug approval and their evolutions.The interactions of the U.S.Patent Law and the FDA laws in promoting the biomedical innovation in the United States are also analyzed.Based on these analyses,suggestions are proposed to promote biomedical innovation in China.