Delays in approvals due to disrupted work schedules at FDA because of the coronavirus are likely to be fewer in the coming months. The biggest current issue preventing approvals looks to be completion of foreign inspections of manufacturing facilities, particularly in Asia. A significant number of complete response letters and extended user fee dates have been issued by the agency due to the inability to complete the inspections.
Policy & Legal, Research
April 2023 PDUFA Calendar
27 March 2023
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