Telecon - Information Request, May 1, 2009 - Menveo

System Info - 110657  VALENTI, ELIZABETH   12-Nov-2009 14:41:05  VALENTI

RECORD OF TELEPHONE CONVERSATION

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

Product:
Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

Applicant:                                                                       
Novartis Vaccines and Diagnostics, Inc.          

Telecon Date/Time:  01-MAY-2009 02:31 PM              Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  CARA FIORE

Telecon Summary:
requested 24 month stability data for final product

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
From:                     Fiore, Cara 
Sent:                      Friday, May 01, 2009 2:31 PM
To:                          'christopher.webster@novartis.com'
Cc:                          Valenti, Elizabeth
Subject:                Stability data
Importance:        High

Hi Chris,

I just left you a voice mail regarding stability data.  We are looking for the stability data at the 24 month time point.  This would have to be from the final  formulation that you are planning on marketing. Evidently, in the BLA is 18 months, but not up to 24 months, which is your shelf life.  Also, there is testing performed at the 24 month that is not routinely tested in the middle time points (one such one is sterility).  Can you let me know if you plan on submitting it, or it is indeed in the BLA or one of the amendments?

I am out of the office, so email is the easiest way to get a hold of me.

Thanks,
Cara