New Drugs Show How FDA Incentives Look Beyond Innovation
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA’s first-in-class drug approvals show a healthy rate of innovation, but the 2014 novel agent cohort is more notable for the high level of clinically meaningful advances in therapy for serious diseases. Two-thirds of CDER’s novel approvals qualified for at least one expedited development and review program; only half of those products represent a new pharmacologic class.