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Vaccines, Blood & Biologics

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Vaccines

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