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Vaccines

Record of Telephone Conversation - Cervarix, March 19, 2008

System Info - 99603  SHONE, DEANNA   15-Jul-2009 16:35:18  SHONEDE

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:  19-MAR-2008 12:56 PM              Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  HELEN GEMIGNANI

Telecon Summary:

Information Request regarding Excel files in Safety Output

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

From: Sullivan, Helen M
Sent: Wednesday, March 19, 2008 12:56 PM
To: 'Matt.Whitman@gsk.com'
Cc: Sharon.W.Shapowal@gsk.com
Subject: RE: Question regarding Excel files in Safety Output

Matt,

Thank you for keeping the reviewers in mind on these types of matters. Please do not submit the data in Excel format to the BLA. Submit the data in xpt format as per regular eCTD requirements.

Helen