Expedited regulatory pathways: EU and US approaches
A timely market introduction is a critical component of any drug development strategy as there is a logical chain of events and tasks to plan and monitor. As the world is waiting for new therapies, complex regulatory requirements is walking a thin line between slowing down the drug availability to the patients or rushing the procedure and perhaps putting citizens at risk.
In this white paper Dr Frank Casty, Judith Plon and Dr. Steffen Thirstrup scrutinize the different pathways in the ‘speed-to-market toolbox’, sharing insights of what to consider while choosing the road to your pre-decided endpoint
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