

Record of Telephone Conversation, October 18, 2012 - Flucelvax

 
 
 

Submission Type: BLA    Submission ID: 125408/0    Office: OVRR

Product:

Influenza Virus Vaccine

Applicant:

Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 18-Oct-2012 02:00 PM        Initiated by FDA? Yes

Telephone Number: 617-871-8325

Communication Categorie(s):

1. Advice

 

Author: TIMOTHY NELLE

Telecon Summary:

Request to withdraw Comparability Protocol and a Validation Master Plan for -(b)(4)--

FDA Participants: None

Non-FDA Participants: Matthew Gollwitzer

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

Telecon Body:

 

CBER requested that the Comparability Protocol and Validation Master Plan to support eventual licensure of –(b)(4)-- be removed from the current BLA package. CBER stated that they had reviewed this information and do not consider the Comparability Protocol in sufficient detail to allow an adequate assessment. Instead of trying to resolve all of the concerns before approval, CBER recommended that Novartis withdraw this information from the current BLA. CBER also recommended that Novartis request a meeting with DMPQ at a later date to discuss their plans for licensing –(b)(4)--.

 

 
 

    
 


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•Approval History, Letters, Reviews, and Related Documents - Flucelvax 
       


   Page Last Updated: 12/19/2012  
