Simultaneous advice from FDA and EMA? Very few companies go that route with new drugs, review finds
Officials from the US FDA and European Medicines Agency put together an overview of the simultaneous scientific reviews from both agencies over a five-year window, and it’s safe to say this dual review process has not yet gone mainstream.
While companies have been able to obtain FDA-EMA joint reviews for new products for the last 15 years, this new five-year review (2017 to 2021) shows just 22 drug development programs actually went through the parallel FDA-EMA review.
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