EU Accelerated Assessment Tracker

Novartis Fails To Secure Fast-Track Review For Trabecta

 
• By Maureen Kenny
  
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Novartis is one of the latest companies to fail in its attempt to have a marketing authorization application fast-tracked at the European Medicines Agency. There was better news for BioMarin. 

This tracker provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a decision. It also tracks whether companies retain fast-track status for MAAs as they make their way through the EU centralized procedure.

Fast-track review can cut a few months off the approximately 12 months it generally takes to review an application under...

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