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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Telecon Memo - 8/29/2007 - AFLURIA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Vaccines Research and Review
Division of Vaccines and Related Products Applications

Telecon Memo

Date:August 29, 2007
To:The File of STN 125254
From:Rakesh Pandey, Ph.D.
Sponsor: CSL Limited.
Subject:Advice/Information request telecon for STN: 125254: BLA for Influenza Virus Vaccine, (Afluria®).

I contacted Paul Hartmann of CSL Behring to communicate that the revisions made by.

I mentioned that I had some reservations about the use of distributor name as"CSL Biotherapies" being on some of the labels. He provided an explanation for this which may be acceptable, as it was done for their other products as well.

I expressed our concern on the lack of information concerning the residual BPL, which was also mentioned in CBER information request of August 20, 2007 fax (comment 15). It has been brought to the attention of Parkville staff and it looked as though they do not have information concerning the level of BPL ---------------------------------------------------
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I also asked a question about endotoxin testing step and reference standard. I also informed them that our staff who conducts product testing is looking into these issues.