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Vaccines, Blood & Biologics

Record of Telephone Conversation - Cervarix, August 25, 2009

System Info - 107046  SHONE, DEANNA   06-Oct-2009 17:32:05  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:  25-AUG-2009 05:22 PM               Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  HELEN GEMIGNANI

Telecon Summary:

Stats Information Request

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:


Sent to GSK 8/25/2009

Helen Gemignani to Matt Whitman

Information Request

Please send the subject PIDs that are associated with each case in Table 13.

 

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