Record of Telephone Conversation - Cervarix, June 19, 2008

System Info - 94741  SHONE, DEANNA   20-May-2009 17:34:22  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:  19-JUN-2008 12:00 AM               Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Advice

Author:  HELEN GEMIGNANI

Telecon Summary:

Email: Communication BLA 125259/0

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

From:                     Gemignani, Helen S 

Sent:                      Thursday, June 19, 2008 6:47 AM

To:                          'Matt.Whitman@gsk.com'

Cc:                          'Sharon.W.Shapowal@gsk.com'

Subject:                June 19 Communication BLA 125259/0 - Upload to EDR

Matt,

We have the following items to present to GSK for brief discussion at our meeting on Tuesday:

1)  CBER requests that safety reports submitted to IND -b(4)-, after December 31, 2007, also be submitted to the BLA 125259.

2)  CBER requests that monthly updates of number of doses distributed of Cervarix by country (EU, Mexico, Australia, Singapore, and Philippines) be submitted to the BLA. 

 

Helen Sullivan Gemignani

Regulatory Project Manager

Division of Vaccines and Related Products Applications

Office of Vaccines Research and Review

Center for Biologics Evaluation and Research

Food and Drug Administration

(301) 827-3070