
Record of Telephone Conversation, October 5, 2012 cont - Flucelvax
 

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

Product:

Influenza Vaccine (MDCK Cells)

Applicant:

Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 05-Oct-2012 11:00 AM        Initiated by FDA? Yes

Telephone Number: 617871-8325

Communication Categorie(s):

1. Information Request

 

Author: TIMOTHY NELLE

Telecon Summary:

CTAB Data from in processing steps ----(b)(4)------

FDA Participants: Timothy Nelle

Non-FDA Participants: Matthew Gollwitzer

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

Telecon Body:

 

CBER requests CTAB measurement data for process monitoring points (b)(4) ------------------------------------------------(b)(4)----------------. The amount of data to be submitted should represent at least 3 release lots.   In other words, we expect that CTAB results from each batch that is ultimately used to constitute three trivalent lots will be included in NVD’s response to this request.