‘Complete Response’ Letters
Executive Summary
Details of action letters issued by FDA, regularly updated with new announcements.
The following chart lists “complete response” actions for pending and recently resubmitted applications; for details on resubmissions, see the User Fee Goal Dates
chart on the FDA Performance Tracker. FDA stopped issuing “approvable” and “not approvable” letters in favor of “complete response” letters in 2008. For still-pending “approvable” and “not approvable” actions, see archived information: (Also see "‘Complete Response’ Letters" - Pink Sheet, 17 Mar, 2015.).
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