Filing Meeting Email, February 1, 2012 - Octaplas

From: Drabick, Christine
Sent: Wednesday, February 01, 2012 9:52 AM
To: Rana, Pratibha; Kirschbaum, Nancy
Cc: Holobaugh, Patricia
Subject: Filing Memo: STN 125416/0 Octapharma, OctaplasLG

This email serves to document that based on my initial review of the clinical data contained in submission BLA STN 125416/0 for Octapharma’s OctaplasLG, the Bioresearch Monitoring Branch finds this submission acceptable for filing.

 

Christine Drabick, HFM-664

Bioresearch Monitoring Branch

Division of Inspections and Surveillance

Office of Compliance and Biologics Quality