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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, October 2, 2012 - Octaplas

 

From:                    Rana, Pratibha
Sent:                      Tuesday, October 02, 2012 5:02 PM
To:                         Rangetiner, Barbara; Ammons, Stanley
Subject:                 SNT 125416/0 Information Request 10-2-2012
Our Reference: STN 125416/0
Octapharma Pharmazeutika Produktionsges.m.b.H.
 
Attention: Mr. Stanley Ammons
Octapharma USA, Inc.
 
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:
 
1.     In your recent response to our request for information regarding assay validation for your viral validation studies, your have indicated that "The ----(b)(4)-------------------------(b)(4)------------------------------------------ are not currently intended to be validated". Based on your response, please clarify the validity of clearance data for    ----(b)(4)---- that you have submitted in your BLA, under Study numbers: 2/09/01/950/3/02 (--(b)(4)--) and 2/10/04/950/3/18 (-(b)(4)-).
 
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 October 5, 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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