Record of Telephone Conversation - Cervarix, October 2, 2009 with Attachments

RECORD OF TELEPHONE CONVERSATION

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

Product:

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Applicant:                                                                        

GlaxoSmithKline Biologicals          

Telecon Date/Time:  02-OCT-2009 05:05 PM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Other

Author:  HELEN GEMIGNANI

Telecon Summary:

Postmarketing Comments Follow Up and Request for Additional Information

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

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From: nicholas.perombelon@gskbio.com [mailto:nicholas.perombelon@gskbio.com]
Sent: Friday, October 02, 2009 5:05 PM
To: Gemignani, Helen S
Cc: Cynthia.A.D'Ambrosio@gsk.com; Matt.Whitman@gsk.com
Subject: RE: Cervarix - Postmarketing Comments Follow Up and Request for Additional Information

Dear Helen,
Please find attached our responses to the questions raised in your mail of September 30, 2009 and the earlier mail of September 16, 2009.
With respect to analyses of SAEs, timeframes for following the various events, and the suggestion to use self controls, GSK has requested further clarification from CBER in the responses and to this purpose we would be willing to have a teleconference call with you to allow us to reach an understanding as soon as possible.
We will also submit the response documents to the BLA.
Thanks and best regards,
Nicholas

 

Attachments:

Responses to September 16, 2009 Comments

Responses to CBER September 30, 2009 Comments