【摘要】 FDA突破性治疗药物指定评审新政的实施填补了治疗某些疾病药物的空白,并得到制药企业的积极响应。药品评价与研究中心(CDER)截止到2015年3月,生物药品评价与研究中心(CBER)截止到2015年1月,FDA共收到299项突破性治疗药物申请,其中授权87项,拒绝161项,其余51项处在审查中,2014年5月—2015年3月获批了18项突破性治疗药物,从药物治疗类别、作用靶点或机制、获得批准上市情况以及不良反应等方面重点介绍其中的突出品种。更多还原

【Abstract】 The implementation of new policy of breakthrough therapies designation drugs approved by FDA fills the blank for the treatment drugs of certain diseases, and it has got a positive response from the pharmaceutical industry. By the end of March 2015 of Center for Drug Evaluation and Research(CDER), January 2015 of Center for Biologics Evaluation and Research(CBER), FDA received total 299 requests for breakthrough therapies designation drugs, of which 87 requests were granted, 161 requests were denied, and the other 51 requests were under examination. Eighteen breakthrough therapies designation drugs were approved from May 2014 to March 2015, and the outstanding varieties of which are introduced from drug treatment category, targets or mechanisms, the situation of approval, and adverse reaction.更多还原