Posted by Michael Wonder on 03 Oct 2018
ADMA Biologics resubmits biologics license application for RI-002
1 October 2018 - ADMA Biologics announces that the Company has responded to the July 2016 complete response letter and resubmitted its biologics license application for RI-002 its product candidate to the U.S. FDA on 28 September 2018.
The Company was able to resubmit RI-002’s application as a direct result of the recent improvement in compliance status for the Company’s Boca Raton, FL manufacturing facility to voluntary action indicated, as previously announced in September 2018.
