摘 要 美国FDA的“研究新药申请”为新药临床试验申请，新药的审批工作主要由美国FDA的药品审评与研究中心和生物制剂审评与研究中心负责。本文介绍美国FDA新药临床试验申请的审核程序、临床试验的监管方式、药品审评的沟通机制和FDA的审评资源，并提出了对我国临床试验申请审批的借鉴建议。

    关键词 美国FDA 新药 临床试验

    中图分类号：R951 文献标志码：C 文章编号：1006-1533(2019)03-0064-03

    Application of new drug clinical trial and drug approval in FDA

    TAN Yan*

    (School of Medical Devices， Shanghai University of Medicine & Health Sciences， Shanghai 201318， China)

    ABSTRACT Investigational New Drug Application (INDA) in FDA is an application of new drug clinical trials. The approval of new drugs is mainly carried out by the FDA’s Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. The INDA review process ......