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EU Accelerated Assessment Tracker

Executive Summary

Accelerated assessment requests at the European Medicines Agency.

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The European Medicines Agency will fast-track Shionogi’s new antibiotic, cefiderocol, through regulatory review when the company files for approval but there’s no special treatment for Roche’s new tissue agnostic oncologic, entrectinib. More than half the accelerated assessment requests made in 2018 to the EMA failed to make the grade.

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EU Accelerated Assessment Tracker

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