European CHMP Opinions And MAA Updates
This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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Three companies are set to learn this week whether the European Medicines Agency will fast track its review of their soon-to-be-filed EU marketing applications.
Janssen and AstraZeneca are among a raft of companies that might this week find out whether the European Medicines Agency will recommend approval of their products for expanded therapeutic indications.
Oral explanation meetings are due to take place this week for drug sponsors who have a final chance to address questions and concerns the European Medicines Agency has about their marketing applications.