FDA met 89% of its PDUFA goals in 2023

Although 2023 was the second busiest year for new drug approvals by the FDA since the Prescription Drug User Fee Act of 1993 was enacted, it was not a particularly strong year for meeting PDUFA goal dates.

In each year from 2015 to 2022, FDA’s Center for Drug Evaluation and Research (CDER) met its target action dates in 95-100% of applications, making 2023’s 89% the lowest percentage in nine years.  ...