ARTICLE | Regulation

EMA’s approach to expedited approval offers lessons for FDA

Annual check-ins with agency promote sponsor discipline, provide validation 

September 1, 2021 1:09 PM UTC

Though inspired by FDA’s accelerated approval pathway, EMA has built its system for expedited approval with a few cardinal differences that solve some pitfalls, but create other challenges, for sponsors.

In the past 15 years, the two agencies have notched roughly the same number of expedited approvals, with a marked uptick in Europe in the last three years...

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