What does the reorganization of CDERs Office of Compliance have to do with risk management?
CDER’s Office of Compliance recently created a new division of Compliance Risk Management and Surveillance to enhance the Office’s capacity to implement risk management approaches. The responsibilities for this division will include analysis of the data documenting manufacturing and drug quality problems to identify trends and patterns to better focus scarce inspectional resources on areas where FDA oversight and intervention are most likely to have the greatest public health impact. back to top Product Specialists 21. Will the increased use of ‘Specialists’ on pre-approval inspections affect PDUFA deadlines/timelines for application review processes? We are very sensitive to this issue and believe specialists can be incorporated on pre-approval inspections without jeopardizing achievement of PDUFA performance goals. Additional scientific input into the inspection process will assist in resolving many potential issues up front, with the potential to help minimize any delays in the revi
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