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US Office Of New Drugs Revamp Taking Shape: More Review Divisions Coming, But Who Will Lead Them?

 
• By Kate Rawson

FDA reaches final stages of reorganization that will better distribute an ever-increasing review workload; recent high-level departures will make filling even more management slots difficult.

FDA entrance sign 2016

The US FDA's reorganization of the Office of New Drugs will likely include the addition of several more review divisions to better manage the workload for division directors and their staff.

Increased responsibilities under the user fee system – plus FDA’s increased interest in engaging directly with patients – has resulted in more meetings and face-to-face interactions between external stakeholders and review division leadership

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