Margaret Hamburg, commissioner of the US Food and Drug Administration (FDA) since early in the Obama administration, announced plans on February to resign by the end of the month. After she leaves, FDA chief scientist Stephen Ostroff will serve as interim commissioner. Although her departure is being greeted with mixed reviews, there is little doubt that FDA is approving products at a faster clip than when she arrived, with more and more of them approved within their respective Prescription Drug User Fee Act (PDUFA) review goal dates. In 2014, for example, the agency approved more than 50 novel drugs and biologics, compared to 27 in 2013. FDA also moved early in 2015 toward approving its first biosimilar product, a step that had sometimes appeared insurmountable for the agency to take. “PhRMA [Pharmaceutical Research and Manufacturers of America] salutes the work of Commissioner Hamburg and recognizes her significant contributions to the thoughtful regulation of medicines, including science as a basis for better regulatory decisions,” says John Castellani, president and CEO of PhRMA in Washington, DC.