Is the FDA walking the talk with supporting innovation?

By Dr Nicola Davies

As discussed in last month’s column, The FDA’s take on Medical Innovation, the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) strives to support the innovation and development of novel drugs and biological products. 1

Many of the broad range of   by the CDER each year are new molecular entities (NMEs) containing an active moiety that has not been previously approved by the FDA. Given that innovation within drug development is key to advancing health care, this article presents some of the innovative drugs approved by the FDA in the fiscal year 2019 – demonstrating that the Administration is walking the talk in supporting innovation.