
Record of Telephone Conversation, April 30, 2012 - Q-Pan

 
 


Submission Type: BLA


Submission ID: 125419/0


Office: OVRR


 Product:
 Influenza A (H5N1) Virus Monovalent Vaccine

Applicant:
 GlaxoSmithKline Biologicals

Telecon Date/Time: 30-Apr-2012 11:48 AM Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
 1. Information Request

Author: CARMEN COLLAZO-CUSTODIO

Telecon Summary:
 356h form and SRID testing

FDA Participants: CARMEN COLLAZO-CUSTODIO

Non-FDA Participants: Michael Schwartz

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


From: Collazo, Carmen 
Sent: Monday, April 30, 2012 11:48 AM
To: 'Michael Schwartz'
Cc: 'Kati Abraham'; Wally, Jeremy; Prutzman, Kirk C; Collazo, Carmen
Subject: Information Request STN 124419 Q-Pan H5N1

Dear Michael,

We have the following request for information:
1.Please submit a revised 356h form reflecting the correct license information.
2.CBER received the monovalent -(b)(4) but need the following information: a.Please indicate the reagents used in the SRID testing.
b.Please provide the SRID results you obtained with the monovalent lots: -----------------(b)(4)-----------------------------------.


Thank you!!

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
