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Vaccines, Blood & Biologics

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 PikeRm. 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

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