1. Pink Sheet
  2. >>Regulatory Trackers
  3. >>US FDA Performance Tracker

Complete Response Letters

Details of complete response letters issued by the US Food and Drug Administration when an application’s review cycle is complete and the application is not ready for approval. Updated weekly.

The chart also 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 (*)