Hamburg highlights report on FDA approvals

In a blog post on Thursday, FDA Commissioner Margaret Hamburg said a recent report that found that the agency approves NMEs faster than its European and Japanese counterparts highlights FDA's "innovative and flexible approach to drug development and approvals." According to the report, published last month by the U.K.'s Centre for Innovation in Regulatory Science (CRIS), the median time to approval of NMEs -- known as new active substances (NAS) in Japan and Europe -- was 304 days in 2013 in the U.S. compared to 478 days in Europe and 342 days in Japan. The report does not address why FDA's average review time is less than its counterparts. ...