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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, April 04, 2012 - Bivigam

 

From:                    Cagungun, Nannette
Sent:                      Wednesday, April 04, 2012 5:47 PM
To:                         'Matthew Vaughn'
Cc:                         Rana, Pratibha; Tilghman, Tracy
Subject:                 Information Request
 
Importance:           High
 
Dear Mr. Vaughn:
 
This information request is being sent on behalf of Pratibha Rana. 
 
This is regarding your BLA submission, STN 125389/0, for Immune Globulin Intravenous (Human). We determined that the following information is necessary to continue our review :
 
            1. Please clarify how the LRF was calculated using -(b)(4)- for the ----------(b)(4)-- assay in this BLA.
 
Please submit your response to this information request as an amendment to this file by close of business on Thursday, April 5, 2012, referencing the date of this request. If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified.
 
The action due date for this file is April 26, 2012.
 
If you have any questions, please contact Ms. Rana at (301) 827-6124. 
 
Nannette Cagungun, MS, PD, RAC
Regulatory Project Manager
OBRR/CBER/FDA, HFM-380
1401 Rockville Pike Rockville, MD 20852-1448
Tel: (301) 827 6174
Fax: (301) 827 2857
Email: nannette.cagungun@fda.hhs.gov
 
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