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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, February 5, 2013 - RIXUBIS

 

From:                              Thompson, Edward
Sent:                               Tuesday, February 05, 2013 1:32 PM
To:                                  'Kevin Smyth (kevin_smyth@baxter.com)'
Cc:                                  Ovanesov, Mikhail V.; Peng, Ze
Subject:                          Information Request for Original BLA 125446/0
 
Contacts:                        Kevin Smyth
 
Dear Mr. Smyth:
 
We are reviewing your August 28, 2012 biologics license application (BLA). We determined that the following information is necessary to continue our review:
 
1.     With reference to the FDA Guidance for Industry: Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, please provide assurance that the production process is not prone to contamination by adventitious virus by performing in vivo tests at least once on cells at the limit of in vitro cell age used for production, i.e., end-of-production cells.
 
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 March 4, 2013 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.
 
If we determine that your response to this information request constitutes a major amendment, we will notify you in writing. 
 
The action due date for this file is tentatively June 30, 2013.
 
If you have any questions, please contact me at (301) 827-9167.
 
Sincerely,
 
 
Edward Thompson
Regulatory Project Manager
FDA/CBER/OBRR/DBA/RPMB
 
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