Proving Ground For “Breakthrough” Status Coming With Impending User Fee Goals
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Novel drug and biologic applications with user fee goals in 2014’s second half cluster around infectious disease – notably hepatitis C, with three “breakthrough” drugs pending, antibiotics and meningitis B vaccines (also designated “breakthroughs”) – and oncology, where the first regulatory tests of the highly anticipated PD-1 immune checkpoint inhibitors are coming up.