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Vaccines, Blood & Biologics

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BiMo Clarification - Cervarix, May 22, 2007

Sullivan, Helen M
RE: May 21 Request
Tuesday, May 22, 2007 11:58:16 AM
Yes, please expand the information in section 6.2.3 of the report and provide center specific and detailed deviation report as requested.
From: Sharon.W.Shapowal@gsk.com [mailto:Sharon.W.Shapowal@gsk.com] Sent: Tuesday, May 22, 2007 10:01 AM To: Sullivan, Helen M Subject: Re: May 21 Request
Dear Helen: I have discussed with GSK biometrics this request. The all-inclusive listing could be produced, but does not exist at this date. We wanted to assure that the FDA BiMo group has considered the information in section 6.2.3 of the report before creating the listing. It may be that the level of detail is not sufficient for their purposes, but it may be. I'm simply checking before we do the work of creating the table. Our biometrics team would, essentially, expand on the information in this section. Is that correct?
Thanks and kind regards,
S.W.Shapowal Director, Adult Vaccines
(610) 787-3763 (internal: 8-275-3763)
"Sullivan, Helen M" <helen.sullivan@fda.hhs.gov>
To Sharon.W.Shapowal@gsk.com 21-May-2007 18:52 cc Subject May 21 Request
May21 BiMo Request for Information. <<May 21 BiMo request.pdf>>
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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