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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 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)---------------.