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Vaccines, Blood & Biologics

Record of Telephone Conversation, October 31, 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 (dba GlaxoSmithKline)

Telecon Date/Time: 31-Oct-2012 07:59 AM Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Information Request

Author: CARMEN COLLAZO-CUSTODIO

Telecon Summary:
Request for CRFs for several subjects in study Q-Pan-002

FDA Participants: Carmen Collazo, Kirk Prutzman, Jeremy Wally

Non-FDA Participants: Michael Schwartz, Jillian Horvath, Robert Brobst

Telecon Body:
The following was communicated to GSK via e-mail correspondence.


From: Collazo, Carmen
Sent: Wednesday, October 31, 2012 7:59 AM
To: Michael Schwartz
Cc: Jillian Horvath; Robert Brobst; Prutzman, Kirk C; Wally, Jeremy
Subject: STN 125419 - Clinical IR (please respond ASAP)
Importance: High

Dear Dr. Schwartz,

Please provide the following CRFs for subjects 1666, 5677, 7906, and 7939 in Study Q-Pan 002. If at all possible, please provide these CRFs by e-mail correspondence by COB today (October 31, 2012) and then follow with an official submission to the BLA. Thank you!

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

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