Telecon - 36 month dating and PVP plan, November 3, 2009 - Menveo

System Info - 109815  SHONE, DEANNA   03-Nov-2009 17:18:46  SHONEDE

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:  03-NOV-2009 12:32 PM               Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Advice

Author:  CARA FIORE

Telecon Summary:
36 month dating and PVP plan

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

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From: Fiore, Cara
Sent: Tuesday, November 03, 2009 12:32 PM
To: 'christopher.webster@novartis.com'
Cc: Valenti, Elizabeth; Fiore, Cara
Subject: 36 month expiry, PVP, summary
Hi Chris, a few things:

1 - regarding the 36 month expiry, I talked to the folks here and this is what we came up with:

1. Since Novratis requested 24 months in the BLA, you must formally request 36 month dating in an amendment to the BLA. The amendment should also contain the data in support of the 36 month dating.
2. Current expectations are that a comparability protocol (CP) must be approved to allow for extension of expiration date of intermediates and final product to be reported in your Annual Report. A stability protocol contained in your BLA is not viewed as a CP. A CP should contain a stability protocol with specifications that must be met. A request for annual reporting of extension of expiration dating must be included with approval of a CP. Approval of this requested will be directly spelled out in the approval letter.

2 - I also wanted to remind you that Novartis should submit their Pharmacovigilance plan for Menveo for our review.

3 - I am planning on faxing the summary of the Sept 22 Type A meeting to you today. Can you please confirm delivery with an email?

Thanks,
Cara