作者简介

何如意, MD

Medical Team Leader

Division of Gastroenterology Products

CDER/FDA                                                                                                             

新药(包括植物药)临床试验/上市申请及审批

摘要：

Organizations – Where to fill your application

何处递交你的申请

Overview of Drug Development

如何有效地与FDA沟通交流

Applications:

–IND:  Investigational New Drug (Application)

新药临床试验的申请及审批

–NDA:  New Drug Application

新药上市的申请及审批

–ANDA: Abbreviated NDA

无专利药的申请及审批

–    中药作为食品添加剂的申请及审批

Questions

讲稿内容PPT下载

如有不明事宜，可通过电子邮件与作者联系ruyihe@yahoo.com