美国FDA批准新药十年（2007～2016）纵观分析

《国际药学研究杂志》发表年度美国FDA批准药物简介已有10年。每种药物自首次获批后，随着临床实践和治疗患者累计数量的增加，必然出现新的问题。如适应证变化；补充修改疗效和临床数据；新适应证的增补；剂量、剂型和给药方式的不断完善；出现新的、严重甚至致命性不良反应时，需要补充禁忌症、警告和注意事项，甚至增加黑框警告等。总之，说明书的所有条目都有可能被修改、补充或删除。更重要的是，10年纵观分析也会发现一些突出的事件，如批准新分子实体（NME）和新生物制品的数量在2015年出现一个明显的高峰。为此，本文从纵向研究10年间发生的突出历史事件，以期对新药研发提供指导和借鉴。

New drugs approved by the U.S. FDA(2007-2016):a review

The introductions of the new drugs approved by the U.S. FDA have been published in the“Journal of International Pharmaceutical Research”for ten years. However,new problems might emerge with the increasing clinical practice and the cumulative number of patients being treated,such as the indications and purposes change,supplement of the modified efficacy,clinical data and the important new indications,constant improvement of the dosage,form and mode of administration,and the emergence of new,seri?ous and even fatal adverse reactions urge the supplements of contraindications,warnings and precautions,or even the black box warn?ings. In brief,6 entries of the introductions all may be modified,supplemented or canceled. More importantly,ten years of general analyses also find some prominent events,such as the amount of new molecular entity(NME)and new biological products come to an obvious peak in 2015. With regard to this,this paper reviewed the prominent historical events happened in the ten years in order to provide guidance and reference for new drug research and development.