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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, May 27, 2011 - Kedbumin

From:                     Allard, Crystal
Sent:                      Friday, May 27, 2011 10:24 AM
To:                         'Urs Aeberli'
Cc:                         --------------------(b)(4)---------------------
Subject:                 Kedrion 125384/0 - Information Request

Importance:           High
Hi Urs,

I have another last minute information request for you:

This is to further clarify our position with regard to reprocessing of a manufacturing step, and also to provide you a feedback on Amendment # 14 that you have submitted to your BLA in reference to reprocessing. Please note that reprocessing of certain manufacturing steps, such as re-filtration may be allowed if supported by sufficient validation data that have been reviewed and found acceptable by CBER.  If validation data has not yet been submitted, you may request reprocessing of a given step in your manufacturing process and submit the validation data as a supplement, upon approval of your current BLA.

Please respond by the end of the day, Monday May 30. We can discuss this in Tuesday's Telecon, if necessary.

Thanks,

Crystal Allard, RAC
Regulatory Project Manager
U.S. Food & Drug Administration
CBER/ OBRR/ DBA/RPMB
WOC1; RM480N; HFM-380
1401 Rockville Pike
Rockville, MD 20852
Ph# 301.827.3927
Fax# 301.827.2857
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