The number of new drugs approved by FDA in 2014 is expected to exceed 39

Source: e-drug Facebook 2014-9-12 FDA's annual number of new drug approvals has been regarded as one of the important indicators reflecting the agency's efficiency Because pharmaceutical companies, their investors, and even the lives of patients can be said to be hanging here In 2014, the FDA released a lot of good signals As of September 2014, FDA has approved 27 new drugs, including biological drugs, including keytruda, a new cancer drug from mosadon, cerdelga, a new Gaucher disease drug from Sanofi jianzan, jardiance, a new diabetes drug jointly promoted by Lilly and Boehringer Ingelheim, etc This is the same as the number of new drugs approved in 2013 According to this approval rate, FDA's new drug throughput is expected to reach a record 39 in 2014 However, the speed of new drug approval is not regular Because the number of new drug applications that FDA receives each year will never match the number of new drugs that are finally approved for marketing A spokeswoman for the FDA explained that this is because the FDA's evaluation and approval of new drugs are rolling That is to say, by the end of the year, no one knows how many new drugs will come for approval, and how many new drugs will get the marketing pass In March, for example, nine applications were submitted to the FDA In 2013, FDA received 36 new drug applications and approved 27 In 2012, 41 were received and 39 approved In 2011, 40 were received and 31 were approved We see 2012 as the most active year for FDA to approve new drugs, but in fact, FDA can't control when drug companies submit their new drug applications In some years, pharmaceutical companies have submitted more applications For example, in the seven years from 2004 to 2010, the number of new drug applications submitted by pharmaceutical companies exceeded 36 only once, and the number of new drugs approved by FDA to be listed exceeded 27 only once in a year However, in the process of FDA's approval of new drugs, we can see some gratifying phenomena for drug companies For example, in 2013, of the 27 new drugs approved for marketing, 24 (or 89%) passed the first round of approval In other words, the FDA does not require companies to submit additional information, so the application for new drug listing will not be delayed to a new round of evaluation In addition, there are two noteworthy phenomena One is that the number of applications reviewed by the FDA last year is completely up to the standard or even over fulfilled In the United States, according to the PDUFA, the number of new drug reviews by FDA every year must reach a certain standard, so that it can charge a certain number of review fees from enterprises to support the review work On the other hand, 74% of the 27 new drugs approved for listing have chosen FDA as the review agency of new drug listing This proves, on one hand, that the FDA is at least much faster than the European drug administration.