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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, June 19, 2012 - Octaplas

 

From:                    Rana, Pratibha
Sent:                      Tuesday, June 19, 2012 11:09 AM
To:                         'Ammons, Stanley'
Cc:                         Rangetiner, Barbara
Subject:                 STN 125416/0 Information Request ( 6-19-12012)
Our Reference: STN 125416/0
Octapharma USA, Inc.
 
Attention: Stanley Ammons
 
Dear Mr. Ammons:
We are reviewing your December 22, 2011 biologics license application (BLA) for Pooled Plasma, Solvent Detergent Treated (Human). We are providing the following comments and request for additional information to continue our review:
 
Chemistry, Manufacturing and Controls (CMC)
 
1.     With regard to the ---(b)(4)------------------ used for the determination of viral clearance, please provide the validation data generated experimentally that the virus would be detected at the theoretical limit of detection in a ---(b)(4)---- for all of the referenced enveloped viruses.
 
The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission.
 
Please submit your response to this information request as an amendment to this file by July 3, 2012 referencing the date of this request.
 
The action due date for this file is October 22, 2012.
 
If you have any questions, please contact me.
 
Sincerely,
Pratibha Rana
Pratibha Rana, M.S.
Regulatory Project Manager
 
FDA/CBER/OBRR
Division of Blood Applications
1401 Rockville Pike
Rockville, MD 20852
Office: (301) 827-6124
Fax: (301) 827-2857
email: pratibha.rana@fda.hhs.gov
 
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