
Record of Telephone Conversation, October 22, 2012 - 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

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

Telephone Number: 610-787-3435

Communication Categorie(s):
 1. Information Request

Author: CARMEN M. COLLAZO-CUSTODIO

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.

Regards,

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
