“新分子实体”和“新化学实体”的定义以及区别?Q6: What is the difference between a New Chemical Entity and a New Molecular entity? A: An NCE is a drug that contains no active moiety that has been approved by FDA in any other application submitted under FDC Act § 505(b). An NME is a drug that contains an active moiety that has never been approved by FDA or marketed in the U.S.查看更多