Record of Telephone Conversation - Cervarix, May 4, 2009

System Info - 94804  SHONE, DEANNA   21-May-2009 14:08:55  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:  04-MAY-2009 12:00 AM             Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  NANCY MILLER

Telecon Summary:

Clinical: Request for number of worldwide doses distributed up until April 6, 2009.

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

From: Gemignani, Helen S
Sent: Monday, May 04, 2009 3:24 PM
To: 'Matt.Whitman@gsk.com'
Subject: Cervarix - Request for # Doses Distributed

We acknowledge that the recent Resubmission to the CERVARIX BLA did contain the number of doses distributed worldwide up until November 2008.  Please submit, to the BLA, the number of worldwide doses distributed, and Periodic Safety Update Reports (PSURs), up until April 6, 2009.

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

From: Gemignani, Helen S
Sent: Monday, May 04, 2009 3:24 PM
To: 'Matt.Whitman@gsk.com'
Subject: Cervarix - Request for # Doses Distributed

We acknowledge that the recent Resubmission to the CERVARIX BLA did contain the number of doses distributed worldwide up until November 2008.  Please submit, to the BLA, the number of worldwide doses distributed, and Periodic Safety Update Reports (PSURs), up until April 6, 2009.

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

From: Gemignani, Helen S
Sent: Monday, May 04, 2009 3:24 PM
To: 'Matt.Whitman@gsk.com'
Subject: Cervarix - Request for # Doses Distributed

We acknowledge that the recent Resubmission to the CERVARIX BLA did contain the number of doses distributed worldwide up until November 2008.  Please submit, to the BLA, the number of worldwide doses distributed, and Periodic Safety Update Reports (PSURs), up until April 6, 2009.

 

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

From: Gemignani, Helen S
Sent: Monday, May 04, 2009 3:24 PM
To: 'Matt.Whitman@gsk.com'
Subject: Cervarix - Request for # Doses Distributed

We acknowledge that the recent Resubmission to the CERVARIX BLA did contain the number of doses distributed worldwide up until November 2008.  Please submit, to the BLA, the number of worldwide doses distributed, and Periodic Safety Update Reports (PSURs), up until April 6, 2009.

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