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Vaccines

Record of Telephone Conversation - Cervarix, July 30, 2009 AM

System Info - 102432  SHONE, DEANNA   17-Aug-2009 16:06:11  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:  30-JUL-2009 09:00 AM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  HELEN GEMIGNANI

Telecon Summary:

PSURs

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:


From: Gemignani, Helen S
Sent: Thursday, July 30, 2009 9:00 AM
To: 'nicholas.perombelon@gskbio.com'
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'; 'Matt.Whitman@gsk.com'
Subject: Re: PSURs

Yes, CBER would like you to submit the analysis to the BLA.