中美药品说明书管理的法律法规比较*

傅书勇,杨悦,于金冉

Comparison of Laws and Regulations of Drug Instructions Management Between China and the United States of America

Shuyong FU,Yue YANG,Jinran YU

美国制药企业修改药品说明书的基本流程

Basic process of drug instruction modification in American pharmaceutical enterprises