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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, November 8, 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

Telecon Date/Time: 08-Nov-2012 12:12 PM        Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Advice
2. Information Request

Author: CARMEN COLLAZO-CUSTODIO

Telecon Summary:
Additional comments on filling methods, -------(b)(4)---------------------------------.

FDA Participants: Kirk Prutzman, Jeremy Wally, Carmen Collazo

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

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

 


 

______________________________________________
From:                     Collazo, Carmen 
Sent:                      Thursday, November 08, 2012 12:12 PM
To:                          Michael Schwartz; Robert Brobst
Cc:                          Jillian Horvath; Prutzman, Kirk C; Wally, Jeremy; Collazo, Carmen
Subject:                STN 125419 Q-Pan H5N1 - IR comment
Importance:        High

Dear Dr. Schwartz,

In your response to FDA Question 2 on September 10, 2012, regarding the filling of AS03, you confirmed that (b)(4) filling methods, ---------(b)(4)--------------------, are claimed. Please clearly state whether you are seeking approval of (b)(4) methods to be used for commercial filling. Please note that if you would like approval for filling under                 --(b)(4)---, you need to provide results of container closure integrity testing sufficiently sensitive to ----(b)(4)-------. In addition, you need to provide data to support that the level of ---(b)(4)--------- meets the acceptance limits throughout the shelf-life of the product, which can/should be determined as part of your stability program through CCIT testing at the last time point.

Regards,

Carmen M. Collazo-Custodio, Ph.D.
Microbiologist
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
WOC2 RM2236 HFM-481
1451 Rockville Pike
Rockville, MD 20852

Tel. 301-796-2640
Fax: 301-827-3532
E-mail address: carmen.collazo@fda.hhs.gov