Cervarix Final Label Email - Cervarix, October 14, 2009
From: Gemignani, Helen S
Sent: Wednesday, October 14, 2009 10:56 AM
To: 'Matt.Whitman@gsk.com'; 'Cynthia.A.D'Ambrosio@gsk.com'; 'email@example.com'
Subject: Cervarix Final Label (Package Insert) 10.14.2009
Cynthia D'Ambrosio and I spoke this morning about the 10.13.2009 version of the CBER label sent to GSK last night. Over the phone, she and I made minor edits and those edits have been incorporated.
This is considered the final label for the Cervarix BLA.
Helen Sullivan Gemignani
Regulatory Project Manager
Division of Vaccines and Related Products Applications/Viral Vaccine Branch