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Vaccines

Record of Telephone Conversation - Cervarix, July 14, 2009

System Info - 99584  SHONE, DEANNA   15-Jul-2009 15:11:16  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:  14-JUL-2009 05:43 PM     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:

 -----Original Message-----

From: Gemignani, Helen S

Sent: Tuesday, July 14, 2009 5:43 PM

To: 'Matt.Whitman@gsk.com'; 'Cynthia.A.D'Ambrosio@gsk.com'; 'nicholas.perombelon@gsk.com'

Subject: PSURs

We spoke to Cynthia  last week in regard to PSURs. CBER would like the PSURs from March 2009 and May 2009 to be submitted to the BLA.