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Vaccines

Record of Telephone Conversation - Agriflu, November 12, 2008

System Info - 107025 MCWATTERS, BERNARD 06-Oct-2009 15:52:11 MCWATTERS 

RECORD OF TELEPHONE CONVERSATION 

Submission Type: Original Application

Submission ID: 125297/0 

Office: OVRR 

Product: Influenza Vaccine 

Applicant: Novartis Vaccines and Diagnostics, Inc. 

Telecon Date/Time: 12-NOV-2008 12:00 AM 

Initiated by FDA? Yes 

Telephone Number: 

Communication Categorie(s): Information Request 

Author: BERNARD MCWATTERS 

Telecon Summary: Requested clarification of records that are available at the clinical study sites. 

FDA Participants: Bernard McWatters Non-FDA Participants: Joanne Totosy de Zepetnek 

Trans-BLA Group: No

Related STNs: None 

Related PMCs: None 

Telecon Body:

Joanne, 

We understand from your memo dated and emailed to us on October 17, 2008 that the Ethics Committee destroyed all of their original documents. Please clarify whether original study documents are still available at the two study sites (10 and 11). 

JP 

Bernard J.P. McWatters, Ph.D. 

FDA/CBER/OVRR/DVRPA HFM-478 

1401 Rockville Pike rm. 389N 

Rockville, MD 20852 

Office - 301-827-5379