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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

3/7/2008 Email - Rotarix

From: Henchal, Laraine
Sent: Friday, March 07, 2008 4:29 PM
To: 'Donna.2.Boyce@gsk.com'
Subject: RE: Rotarix PI/PPI FDA Version 1

Donna,

I am trying to finish up my own review. I am doing the adventitious agent testing on cells, virus seeds and virus harvests. I am clicking around on all kinds of documents you have in there (including that ultra tricky 3.2.R section) and nowhere can I find who you are buying your ------- from, what is the source country and what testing is done by the vendor and/or GSK for assurance that no adventitious viruses are present? Can you help? Thanks

Laraine S. Henchal, MAS
Microbiologist Reviewer, Team Leader
Viral Vaccines Branch
Division of Vaccines and
Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
Phone: 301-827-3070
Fax: 301-827-3532

______________________________________________________

 

From: Donna.2.Boyce@gsk.com [mailto:Donna.2.Boyce@gsk.com]
Sent: Friday, March 07, 2008 3:30 PM
To: Henchal, Laraine
Cc: Vujcic, Luba
Subject: Re: Rotarix PI/PPI FDA Version 1

Thanks!

"Henchal, Laraine" <laraine.henchal@fda.hhs.gov>
07-Mar-2008 15:02
To Donna.2.Boyce@gsk.com
cc "Vujcic, Luba" <luba.vujcic@fda.hhs.gov>
Subject Rotarix PI/PPI FDA Version 1

Donna,

Here is the first crack at the PI/PPI. We only sent the clean version because this version incorporates as many as five people's comments and was extremely messy in mark-up format. The medical officer tells me that you will know what is meant by the blue note "Please reorder" in the Highlights section. Also, please note we have not yet addressed the potency specification issue. Laraine

<<Rotarix PI (3-7-08) clean copy.doc>>

Laraine S. Henchal, MAS
Microbiologist Reviewer, Team Leader
Viral Vaccines Branch
Division of Vaccines and
Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
Phone: 301-827-3070
Fax: 301-827-3532 [attachment "Rotarix PI (3-7-08) clean copy.doc" deleted by Donna 2 Boyce/PharmRD/GSK]

 

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