Amid rising pressure to endorse new medicines, U.S. regulators greatly outpaced their European counterpart in reviewing and approving new cancer treatments over a recent 10-year period, although they more frequently did so before pivotal studies were published.
Of 89 new cancer medicines approved by both agencies between 2010 and 2019, the U.S. Food and Drug Administration sanctioned 85 of the treatments before the European Medicines Agency. On average, the FDA took 200 days to approve a medicine, compared with 426 days by the EMA. For a given drug, it took an average of 241 days longer to be authorized in Europe than in the U.S.
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