Record of Telephone Conversation - Cervarix, April 14, 2008

System Info - 94742  SHONE, DEANNA   20-May-2009 17:37:33  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:  14-APR-2008 12:00 AM               Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Advice

Author:  HELEN GEMIGNANI

Telecon Summary:

VRBPAC - The CR response has not been submitted in full as of this date and therefore Cervarix will not be able to be presented at a July 2008 VRBPAC.

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No   

Related STNs:  None

Related PMCs:  None

Telecon Body:

From: Gemignani, Helen S
Sent: Monday, April 14, 2008 6:02 PM
To: 'matt.whitman@gsk.com'
Cc: 'Sharon Shapowal (Sharon.W.Shapowal@gsk.com)'
Subject: VRBPAC Information

Matt,

Sharon had inquired about the earliest VRBPAC date at which Cervarix could be presented. At this point, there would not be adequate time to review the complete response and prepare for a July VRBPAC. Upon submission of your complete response (late April as per our most recent communication) we can commence discussion about the next potential VRBPAC date when the Cervarix application can be presented.

Helen

Helen Sullivan Gemignani
Regulatory Project Manager
FDA/CBER/OVRR
Division of Vaccines and Related Products Applications/Viral Vaccine Branch
(301) 827-3070