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Joint FDA/EMEA application reviews, pre-approval inspections encouraged

This article was originally published in The Gold Sheet

Executive Summary

FDA is jointly reviewing some applications with the European Medicines Agency and would like to jointly review more, agency officials on June 2 told the ISPE Washington conference. "Last week I had two teleconferences with EMEA to discuss submissions that have been submitted to both groups," said FDA's Elaine Morefield. "So prior to approval and taking action we're having discussions on trying to get similar agreement so that we're not taking different actions in different countries unless there's some need to." FDA's Rick Friedman encouraged attendees to "please tell us early if you submit a CTD to Europe and the U.S. and it's at the same time ... and you think it would be a nice candidate for a joint pre-approval inspection.

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