Date: October 12, 2010
From: Nannette Cagungun CBER/OBRR/DBA, HFM-380
Subject: Filing of Factor XIII Concentrate (Human) BLA
In lieu of a filing meeting, the review committee members were asked to provide their filing memos to the RPM by September 30, 2010. The review committee did not identify any major deficiencies and unanimously recommended to file the BLA.
A filing letter has been drafted and is currently routing for signatures.