
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
