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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
Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 01-MAY-2009 02:31 PM Initiated by FDA? Yes
Author: CARA FIORE
requested 24 month stability data for final product
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fiore, Cara
Sent: Friday, May 01, 2009 2:31 PM
Cc: Valenti, Elizabeth
Subject: Stability data
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.