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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Meeting, February 8, 2012 pm - Octaplas

 

From:                    Wyatt, Michael (Keith)
Sent:                      Wednesday, February 08, 2012 12:18 PM
To:                         Rana, Pratibha
Cc:                         Kirschbaum, Nancy; Mahmood, Iftekhar
Subject:                 Filing Meeting/STN 125416/0/OctaplastLG/Pratibha
Dear Pratibha
 
Based on a cursory review of the Octaplas LG submission, STN 125416/0, I have not identified any pharm/tox issues that would prevent this BLA from being filed.
 
Keith
 
M. Keith Wyatt, Ph. D.
Pharmacologist
Food and Drug Administration
CBER/OBRR/DH HFM-392
1401 Rockville Pike
Rockville, MD 20852-1448
 
(301) 827-9258
(301) 827-3534 (fax)