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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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.