FDA In Brief: FDA begins reorganization phase of modernization efforts to increase efficiency and further support new drug development

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FDA In Brief: FDA begins reorganization phase of modernization efforts to increase efficiency and further support new drug development

Today, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) announced that the reorganization of certain offices within the New Drugs Regulatory Program (NDRP) has been approved. The new structure will strengthen CDER’s Office of New Drugs (OND) operations and will allow the FDA to better meet the evolving needs of new drug review by increasing the number of reviewing divisions, allowing each to specialize in certain types of drugs, while also increasing the effectiveness and efficiency of review. The Office of Translational Sciences (OTS) and the Office of Pharmaceutical Quality (OPQ), which work closely with OND, are also undergoing a restructuring of...

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