2021 in review: FDA approvals of new medicines.

ABSTRACT

The year 2021 witnessed a remarkable number of US Food and Drug Administration (FDA) approvals and registered clinical trials. In total, 60 new molecular entities (NMEs) were approved by the FDA, the highest level achieved in the post-Prescription Drug User Fee (PDUFA) era and tied with 2018. Of these NMEs, 49 used the incentives of the Orphan Drug Act or were approved under Priority, Fast-Track, Accelerated, and/or Breakthrough designations. Looking further, the number of registered clinical trials was off its 2020 record peak but well within the 5-year running average. Nonetheless, these remarkable outcomes were tempered by the fact that the rate of industry consolidation and turnover continued apace, reducing the number of organizations involved in the clinical development of new medicines and raising questions about long-term sustainability.