Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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.

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts