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Vaccines, Blood & Biologics

Bioresearch Monitoring Comment-Cervarix, April 25, 2007

From: Sullivan, Helen M
To: "Sharon.W.Shapowal@gsk.com";
CC:
Subject: CERVARIX - Bioresearch Monitoring Comment
Date: Wednesday, April 25, 2007 3:29:59 PM
Attachments:
The following comment on the Cervarix BLA, STN 125259, pertains to
Bioresearch Monitoring. Please respond via amendment to the BLA.
m Please specify the reasons for terminating Dr. Hutchison's
participation in Study HPV-008 (i.e., provide specific details
regarding what you describe as "potential study conduct and data
integrity issues" at Site 4923). Please respond as an amendment
to the BLA.
Helen Sullivan Gemignani
Regulatory Project Manager
FDA/CBER/OVRR
Division of Vaccines and Related Products Applications/Viral Vaccine
Branch
(301) 827-3070

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