Complete Response Letters
Executive Summary
Details of action letters issued by US FDA, regularly updated with new announcements.
The following chart lists complete response letters (CRLs) from FDA, including information on the issues raised.
The chart contains information on letters for pending applications and follows the progress of applications resubmitted after mid-2015. For more detailed information on resubmitted applications, see the FDA Performance Tracker's User Fee Goal Dates chart.
Click on any column header to sort. New molecular or biologic entities are indicated with an asterisk (*). To display only these novel products, search * in the search box.