FDA突破性治療藥物指定評審新政的實(shí)施填補(bǔ)了治療某些疾病藥物的空白,并得到制藥企業(yè)的積極響應(yīng)。藥品評價(jià)與研究中心(CDER)截止到2015年3月,生物藥品評價(jià)與研究中心(CBER)截止到2015年1月,FDA共收到299項(xiàng)突破性治療藥物申請,其中授權(quán)87項(xiàng),拒絕161項(xiàng),其余51項(xiàng)處在審查中,2014年5月—2015年3月獲批了18項(xiàng)突破性治療藥物,從藥物治療類別、作用靶點(diǎn)或機(jī)制、獲得批準(zhǔn)上市情況以及不良反應(yīng)等方面重點(diǎn)介紹其中的突出品種。

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.