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

Telephone Number: 610-787-3435

Communication Categorie(s): 
 1. Information Request

Author: CARMEN COLLAZO-CUSTODIO

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.

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
