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Vaccines

Record of Telephone Conversation, October 2, 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: 02-Oct-2012 02:29 PM        Initiated by FDA? Yes

Telephone Number: michael.p.schwartz@gsk.com; robert.d.brobst@gsk.com

Communication Categorie(s):
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary:
IR for qualification test reports for the AS03 Adjuvant

FDA Participants: KIRK PRUTZMAN, CARMEN COLLAZO, JEREMY WALLY

Non-FDA Participants: MICHAEL SCHWARTZ, ROBERT BROBST

Trans-BLA Group: No

Related STNs: None
Related PMCs: None
Telecon Body:

 

From:                     Prutzman, Kirk C
Sent:                      Tuesday, October 02, 2012 2:29 PM
To:                         Michael Schwartz; robert.d.brobst@gsk.com
Cc:                         Collazo, Carmen; Wally, Jeremy
Subject:                 STN 125419 - Qpan - Information Request
Dear Drs. Schwartz and Brobst,

We have the following requests for additional information regarding STN 125419 (Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted):
 

  1. Please provide your bacteriostatic and fungistatic test qualification reports with results for Q-Pan Antigen and AS03 Adjuvant Final container products.

2.   Please provide your bioburden qualification test report with results for the AS03 Adjuvant.

3.   Please provide your ----(b)(4)------------- qualification report for the AS03 Adjuvant FC product.

Please submit your responses in an amendment to the BLA submission.

If you have any questions about this communication, please contact Kirk Prutzman, Carmen M. Collazo, or Jeremy Wally.

Regards,

Kirk Prutzman, PhD
Food and Drug Administration
Primary Reviewer/Regulatory Project Manager
CBER/OVRR/DVRPA/CMC3
1451 Rockville Pike (WOC2)
Room 2241
HFM-481
Rockville, MD  20857
Phone:  (301) 796-2640