Breakthrough therapies designation drugs approved by FDA from May 2014 to March 2015
Xiao Gui-zh · Xiandai yaowu yu linchuang · 2015
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.