The biggest challenge from the “modernization” of the US Food and Drug Administration’s Office of New Drugs over the long haul will be the agency’s continued challenges in filling open positions.
OND Reorg Getting Warm Welcome From Review Divisions
Division directors are embracing the reorganization of US FDA's drug review operations.
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The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.