FDA News

 

CMO Concerns Draw CRL for Navidea’s Lymphoseek

The FDA has sent Navidea a complete response letter (CRL) on its Lymphoseek injection, citing concerns over quality control at third-party contract manufacturing facilities.


300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 - Fax (703) 538-7676 - Toll free (888) 838-5578.
Copyright by FDAnews. All rights reserved. Do not duplicate or redistribute in any form.