
Record of Telephone Conversation, August 21, 2012 am - Flucelvax


 

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

Product:

Influenza Vaccine (MDCK Cells)

Applicant:

Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 21-Aug-2012 11:00 AM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):

1. Other - ---(b)(4)-- discussion

Author: BRENDA BALDWIN

Telecon Summary:

PS80, CTAB and ----------(b)(4)----------------- validation

FDA Participants: Brenda Baldwin, Timothy Fritz, Timothy Nelle, Rajesh Gupta, Lokesh Bhattacharyya, William McCormick, Anissa Cheung

Non-FDA Participants: Matthew Gollwitzer, Umang Shah, Kerstin Platz, Karsten Kattmann, Stefan Knapp, Manfred Brunen, Reinhard Wilms, Holger Kost

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

 

This teleconference was held to discuss --------------------(b)(4)-----------------------------------------------.

CBER noted that both the CTAB and PS80 assays are inadequate for their respective intended use and that NVD ---------(b)(4)-- for establishing alternative methods that are more suitable. -------------------------(b)(4)--------------------------------- asked if they could receive assistance on developing these assays. CBER stated they would provide some references to the alternative assays and could provide additional guidance, if needed. CBER requested that NVD provide a timeline for validating and implementing the assays; however, NVD does not need to provide the technical method yet. It was agreed that NVD would provide the timelines by the end of the week.

 

The issue with the Mycoplasma testing was also raised. CBER stated that an exemption (for not having a (b)(4) based Mycoplasma test) would be allowed for this year, but that NVD would need to provide information (method and timeline for implementation) for a              (b)(4) assay in a timely fashion. NVD indicated they would like assistance in developing the test from CBER. CBER agreed. ---------------------------(b)(4)--------------------------------------------------------------------------------.

 

CBER mentioned the issues regarding residual virus inactivation. CBER noted that the explanations provided in response to questions 11a and 11b (Amendment 12 submitted June 19, 2012) were unsatisfactory and that an adequate response would still need to be provided. It was agreed that further discussion would need to take place in another teleconference later in the week.

 

Final validation reports to support ------------(b)(4)------------------------------------- were also discussed. CBER indicated that a ---(b)(4)---- would be needed and requested that NVD provide a timeline for submitting the reports as soon as possible. -----(b)(4)-----.