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EU Accelerated Assessment Tracker

 
• By Maureen Kenny

The outcomes of six requests for accelerated assessment that companies have made for their planned marketing authorization applications in the EU are still unknown.

The tracker below provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that are known to have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a decision since January 2018.

This latest edition has been updated to reflect the fact that the MAA for Roche’s polatuzumab vedotin (Polivy) has lost its accelerated assessment status and reverted to standard review times....

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