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Record of Telephone Conversation, October 22, 2012 - Q-Pan

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

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

ID Biomedical Corporation of Quebec

Telecon Date/Time: 22-Oct-2012 05:15 PM        Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Information Request


Telecon Summary:
IR comment on GSK's PVP

FDA Participants: Jeremy Wally, Kirk Prutzman, Carmen Collazo-Custodio

Non-FDA Participants: Michael Schwartz, Robert Brobst

Telecon Body:
The following was communicated to GSK via e-mail correspondence:
From:                     Collazo, Carmen 
Sent:                      Monday, October 22, 2012 5:15 PM
To:                          Michael Schwartz; Robert Brobst
Cc:                          Wally, Jeremy; Prutzman, Kirk C; Collazo, Carmen
Subject:                STN 125419:  Additional IR comment on your PVP
Importance:        High

Dear Drs. Schwartz and Brobst,

We have the following comment regarding your U.S. Pharmacovigilance Plan (PVP) for Influenza A (H5N1) Virus Monovalent Vaccine (Version 2: July 2012) provided in your July 18, 2012:

Please provide your plans for a surveillance pregnancy registry in the U.S.


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