Vaccines, Blood & Biologics
Filing Meeting, February 8, 2012 pm - Octaplas
From: Wyatt, Michael (Keith)
Sent: Wednesday, February 08, 2012 12:18 PM
To: Rana, Pratibha
Cc: Kirschbaum, Nancy; Mahmood, Iftekhar
Subject: Filing Meeting/STN 125416/0/OctaplastLG/Pratibha
Based on a cursory review of the Octaplas LG submission, STN 125416/0, I have not identified any pharm/tox issues that would prevent this BLA from being filed.
M. Keith Wyatt, Ph. D.
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
(301) 827-3534 (fax)