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Record of Telephone Conversation, October 2, 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: 02-Oct-2012 02:29 PM Initiated by FDA? Yes
Telephone Number: firstname.lastname@example.org; email@example.com
1. Information Request
Author: KIRK PRUTZMAN
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
From: Prutzman, Kirk C
Sent: Tuesday, October 02, 2012 2:29 PM
To: Michael Schwartz; firstname.lastname@example.org
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):
- 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.
Kirk Prutzman, PhD
Food and Drug Administration
Primary Reviewer/Regulatory Project Manager
1451 Rockville Pike (WOC2)
Rockville, MD 20857
Phone: (301) 796-2640