Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions
Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions
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Changes are coming to the structure of the FDA’s Center for Drug Evaluation and Research division the Office of New Drugs. This long-planned reorganization is still in the nascent stages, but expected to bring a more modern approach that, along with IT improvements and other streamlined processes, will make drug reviews more efficient.
Publisher: Pinksheet
- Description
A proposed restructuring of the US FDA’s Office of New Drugs (OND) would add four new offices to oversee review operations and 11 new drug review divisions to the organization. The goal of this long-planned modernization of the OND? To create smaller, more specialized divisions and balance the workload of the Center for Drug Evaluation and Research (of which the OND is a division). Read more about this important reorg, the challenges associated with its implementation, and its possible impacts here.
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