US Office Of New Drugs Revamp Taking Shape: More Review Divisions Coming, But Who Will Lead Them?
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.
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One goal of proposed overhaul of US FDA’s Office of New Drugs is creating more logical alignment of related diseases within divisions and offices. That is easier said than done.
Long-planned OND 'modernization' to better match workflow, allow more time with stakeholders includes proposed restructuring that would boost number of offices overseeing review operations (adding four for a total of nine) and drug review divisions (adding 11 for a total of 30).