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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, June 21, 2012 - Q-Pan

 

Submission Type: BLA    Submission ID: 125419/0    Office: OVRR
Product:
Influenza A (H5N1) Virus Monovalent Vaccine
Applicant:
ID Biomedical Corporation of Quebec
Telecon Date/Time: 21-Jun-2012 07:42 AM        Initiated by FDA? Yes
Telephone Number: 610-787-3435
Communication Categorie(s):
1. Other -
Author: CARMEN COLLAZO-CUSTODIO
Telecon Summary:
Request for AS03 adjuvant samples and SRID calculation sheet
FDA Participants: CARMEN COLLAZO-CUSTODIO
Non-FDA Participants: Michael Schwartz, Katalin Abraham
Telecon Body:
The following was communicated to GSK via e-mail correspondence. GSK acknowledged receiving this communication.


 

 
 
______________________________________________
From:              Collazo, Carmen 
Sent:               Thursday, June 21, 2012 7:42 AM
To:                  Michael Schwartz; Kati Abraham
Cc:                  Prutzman, Kirk C; Wally, Jeremy; Collazo, Carmen; Campbell, Karen M
Subject:          STN 125419: Request for AS03 adjuvant samples and calculation sheet
 
Dear Mike and Kati,
 
This communication is to request that you provide the following to CBER:
 
1.     Please provide (b)(4) vials (10 mL vials/2.5 mL sample) from 3 final container lots of the AS03 adjuvant. The shipping information is:
 
Attn: Karen Campbell
DBSQC/OCBQ/CBER/FDA
Building B Room 2410
5516 Nicholson Lane
Kensington, MD 20895
 
2.   Please submit the Excel spreadsheet GSK uses for the SRID calculations.
 
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