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
Product: Influenza Vaccine
Applicant: Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 12-NOV-2008 12:00 AM
Initiated by FDA? Yes
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
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).
Bernard J.P. McWatters, Ph.D.
1401 Rockville Pike rm. 389N
Rockville, MD 20852
Office - 301-827-5379