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Vaccines, Blood & Biologics

Postmarketing Safety Data - Cervarix, October 9, 2007

Gemignani, Helen S
From: Sullivan, Helen M
Sent: Tuesday, October 09, 2007 2:24 PM
To: 'Sharon.W.Shapowal@gsk.com'
Cc: 'Matt.Whitman@gsk.com'
Subject: RE: clarification
Sharon,
Your proposals and responses are acceptable to CBER.
Helen
From: Sharon.W.Shapowal@gsk.com [mailto:Sharon.W.Shapowal@gsk.com]
Sent: Friday, October 05, 2007 6:22 PM
To: Sullivan, Helen M
Cc: Matt.Whitman@gsk.com
Subject: clarification
STN 125259/0
Dear Helen:
My team has asked for clarification regarding the FAX of October 2, 2007. I'm attaching a clarifying note back to your
team. Please let us know if our interpretation and/or proposal is acceptable.
Thanks and regards,
Sharon
S.W.Shapowal
Director, Adult Vaccines
(610) 787-3763
(internal: 8-275-3763)
"EMF <fda.hhs.gov>" made the following annotations.
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