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Vaccines

Record of Telephone Conversation - Cervarix, December 20, 2007

System Info - 94743  SHONE, DEANNA   20-May-2009 17:40:01  SHONEDE

RECORD OF TELEPHONE CONVERSATION

 

Submission Type: Original Application   Submission ID:  125259/0    Office: OVRR  

Product:

Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed

Applicant:                                                                       

GlaxoSmithKline Biologicals          

Telecon Date/Time:  20-DEC-2007 12:00 AM               Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Other

Author:  NORMAN BAYLOR

Telecon Summary:

CR Letter: discussion of addressing the major CR letter issues and request for telecon with CBER.

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

From: Baylor, Norman
Sent: Thu 12/20/2007 1:14 PM
To: Clare.Kahn@gsk.com; Houn, Florence
Cc: Barbara.J.Howe@gsk.com; Penney, Melissa
Subject: RE: Suitable time for short TC on Cervarix CR Letter

Dear Clare/Barbara,

I would like to follow-up on one point from our discussion this morning.  I understood you to say that you were comfortable with providing us safety updates on SAEs reported as possibly related to Cervarix through 30 September 2007.  We selected the September timeframe because this was 1 year beyond the 30 September 2006 data lock poiint, and 3 months out from the issuance of our CR letter.  Now, however, since GSK's response to our CR letter may be several months out, I want to clarify that we would like an updated table of events as close to the date of your response to the 14 December 2007 CR letter as possible.  Further, I should also state that we will need an additional update of these events close to the timing of the VRBPAC meeting, as yet to be scheduled.  Please acknowledge that you agree to providing us with this information as per the timelines I have proposed.  Thanks.

 

Norman