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