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


7 October 2020 - The investigators of the study set out to characterise the therapeutic value of new drugs approved by the US FDA and the EMA and the association between these ratings and regulatory approval through expedited programs.

From 2007 through 2017, the FDA and EMA approved 320 and 268 new drugs, respectively, of which 181 (57%) and 39 (15%) qualified for least one expedited program.

Among 267 new drugs with a therapeutic value rating, 84 (31%) were rated as having high therapeutic value by at least one organisation.

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Michael Wonder

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Michael Wonder