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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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)--.