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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, February 19, 2013 - Q-Pan


Submission Type: BLA    Submission ID: 125419/0    Office: OVRR

Product:
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Applicant:
ID Biomedical Corporation of Quebec (dba GlaxoSmithKline Biologicals)

Telecon Date/Time: 19-Feb-2013 02:17 PM        Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Information Request
Author: CARMEN COLLAZO-CUSTODIO

Telecon Summary:

Information request on subjects 1666 and 5677 from study Q-Pan-H5N1-002

FDA Participants: Jeremy Wally, Kirk Prutzman, Carmen Collazo

Non-FDA Participants: Michael Schwartz; Jillian Horvath

Telecon Body:
The following was communicated to GSK via e-mail correspondence.


 

______________________________________________
From:                     Collazo, Carmen 
Sent:                      Tuesday, February 19, 2013 2:17 PM
To:                          Michael Schwartz; Jillian Horvath
Cc:                          Wally, Jeremy; Prutzman, Kirk C; Collazo, Carmen
Subject:                STN 125419 - please provide the following information
Importance:        High

 

Dear Mike,

Reference is made to the response provided in Amendment 25, Module 1.11.2, submitted on February 1, 2013.  Regarding subjects 1666 and 5677 from study Q-Pan-H5N1-002, please identify the page numbers in the Day 182 Annex report (or any other report in the BLA submission) were these diagnoses were reconsidered/reclassified.  Also, please indicate where the Case Report Forms for these subjects were submitted.  Please provide the requested information as soon as possible.  Thank you!

Carmen M. Collazo-Custodio, Ph.D.
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
Office location:
1451 Rockville Pike  Rm. 2236
Rockville, MD 20852

Tel. 301-796-2640
Fax: 301-827-3532
E-mail address: carmen.collazo@fda.hhs.gov

Mailing address:
Center for Biologics Evaluation and Research
Document Control Center HFM-481
1401 Rockville Pike
Rockville, MD 20852-1448