FDA Wants to Clear 364 Forgotten ANDAs on Eve of GDUFA Passage
The FDA’s Office of Generic Drugs (OGD) appears to be taking the first steps to whittling down its almost 3,000-long ANDA backlog, telling drugmakers it will discard 364 pending generic-drug applications unless told otherwise.
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.