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Record of Telephone Conversation, December 3, 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: 03-Dec-2012 08:00 AM        Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Information Request


Telecon Summary:
Request to clarify if –b(4)-----------------------------------------------
FDA Participants: Michael Schwartz, Jillian Horvath, Robert Brobst


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

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


From:             Collazo, Carmen 
Sent:              Monday, December 03, 2012 8:00 AM
To:                  Michael Schwartz; Jillian Horvath; Robert Brobst
Cc:                  Wally, Jeremy; Prutzman, Kirk C; Collazo, Carmen
Subject:        STN 125419 Information request
Importance: High

Dear Dr. Schwartz,

We have the following comment:

In the BLA submission, you state that, "The filtered emulsion is stored under –b(4)----------------------- prior to filling in final containers." Please clarify if –b(4)--------------- is used and state where in the BLA you describe the –b(4)----------------------------------- Please justify your response.


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