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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation - Cervarix, May 4, 2007

Record of Telephone Conversation
STN Number: 125259/0
Manufacturer: GSK
Product: Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed (CERVARIX)
To: File
From: Helen S. Gemignani, Regulatory Project Manager
Subject: Priority Review Request
Telecon Date: 04-May-2007 Telecon Time: 11:50AM
Telecon Initiated by: Helen S. Gemignani
Contact Phone: 610 787-3763
Signature:
Summary of Telecon
I left Sharon Shapowal a voicemail that the Cervarix™ Review Committee and OVRR management discussed GSK's request for Priority Review and it was determined, by OVRR management, that Cervarix™ will be reviewed under a 10 month standard review clock and that documentation of this decision will be included in the Filing Letter.
End of Teleconference
Action Items
• Include 10 month standard review language in the Filing Letter
FDA Participants
• Helen S. Gemignani
Non-FDA Participants
• Sharon Shapowal