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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