US FDA 'Uni-Review' Rolls Out: Psychiatric Division Is Among Early Adopters
Shared review memorandum under Office of New Drugs reorg will help eliminate last-minute surprises between disciplines and provide greater consistency between divisions.
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Detection of nitrosamine impurities in some marketed drugs highlights need for standardized, consistent approach to systematically monitor risks of drugs throughout their lifecycles, CDER’s Janet Woodcock says. Safety monitoring overhaul is lagging behind new drug review modernization effort, but implementation is expected to begin in 2020.
Division directors are embracing the reorganization of US FDA's drug review operations.
A COE modeled after the Oncology Center of Excellence, which stakeholders had proposed, is not in the works, but rather a more virtual structure.