FDA reviews drugs three months faster than EMA, report finds

A new analysis comparing the performance of the US Food and Drug Administration and the European Medicines Agency has found that the FDA approves drugs three to four months faster than its European counterpart.

The report, which comes as the US Prescription Drug User Fee Act (PDUFA) is under review, appears to contradict President Donald Trump’s view that the agency is “slow and burdensome.”

The authors note that the FDA green-lit 170 applications between 2011 and 2015, compared to 144 from the EMA, taking an average of 77 fewer days to reach a decision.