
Record of Telephone Conversation, October 11, 2012 - Flucelvax

 

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

Product:

Influenza Virus Vaccine

Applicant:

Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 11-Oct-2012 02:00 PM        Initiated by FDA? Yes

Telephone Number: 617-871-8325

Communication Categorie(s):

1. Advice

 

Author: TIMOTHY NELLE

Telecon Summary:

Current BPL testing is considered a "limit test", not quantitative.

FDA Participants: None

Non-FDA Participants: Matthew Gollwitzer

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

 

Telecon Body:

CBER informed Novartis that the current BPL assay --(b)(4)---- can used as a ‘limit test’ for the detection of residual BPL in the -----(b)(4)----------, but cannot be used as ‘quantitative assay’ due to matrix interference effects. This means that this test is acceptable for release testing, but will not be acceptable for use in validation studies which are intended to establish BPL ----------(b)(4)---------------.