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Record of Telephone Conversation - Cervarix, August 6, 2008

Record of Telephone Conversation

STN Number:    125259/0

Manufacturer:   GSK

Product:            CERVARIX

To:             File

From:         Helen S. Gemignani, Regulatory Project Manager  

Subject:      Distribution Reports

Telecon Date: 8/6/2008            Telecon Time:   3:11 pm

Telecon Initiated by: Helen S. Gemignani

Contact Phone: 610 787-3752


Summary of Telecon

The following information was conveyed to GSK in response to their request as to whether they needed to submit monthly distribution reports for Cervarix.

1.  GSK can suspend monthly dose distribution reports at this time.

2.  CBER would want to see dose distribution at the time of the final submission for safety updates in the post-marketing period (EU and other countries), and 2 months prior to a scheduled VRBPAC at the time of an additional safety update.

3.  CBER may require doses distributed at the time of an SAE of specific interest.

End of Teleconference

FDA Participants

  • Helen Gemignani

Non-FDA Participants

  • Matthew Whitman
  • Cindy D’Ambrosia