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Vaccines

Telecon - Men A Standard, September 9, 2009

System Info - 104575  SHONE, DEANNA   09-Sep-2009 16:09:33  SHONEDE

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125300/0    Office: OVRR  

Product:
Meningococcal ACWY Conjugate Vaccine

Applicant:                                                                        
Novartis Vaccines and Diagnostics, Inc.          

Telecon Date/Time:  09-SEP-2009 03:42 PM     Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  CARA FIORE

Telecon Summary:
Request for Men A Standard

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
______________________________________________
From:                     Fiore, Cara 
Sent:                      Wednesday, September 09, 2009 3:42 PM
To:                          'christopher.webster@novartis.com'
Cc:                          Valenti, Elizabeth
Subject:                Men A standard

Hi Chris,
We still have not received the MenA polysaccharide internal standard for our in-support testing.  (This should come in as a reagent.)  Please let us know we should expect this.

Cara