
Record of Telephone Conversation, August 29, 2012 - Flucelvax

 
 

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

Product:

Influenza Vaccine (MDCK Cells)

Applicant:

Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 29-Aug-2012 09:16 PM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):

1. Information Request

 

Author: TIMOTHY NELLE

Telecon Summary:

Narratives for the three deaths that occurred during V58P4

FDA Participants: None

Non-FDA Participants: Matthew Gollwitz

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

Telecon Body:

Via secure email, CBER requested narratives for the three deaths that occurred during clinical study V58P4.