Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study

From 2007 to 2017, FDA and EMA approved 320 and 268 new drugs, respectively, of which less than a third were rated as having high therapeutic value (TV) by at least 1 of 5 independent organisations, and most expedited drugs approved by FDA but not EMA were rated as having low TV.

British Medical Journal