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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, June 3, 2013 - RIXUBIS

 

From:                              Thompson, Edward
Sent:                               Monday, June 03, 2013 11:59 AM
To:                                  'Kevin Smyth (kevin_smyth@baxter.com)'
Cc:                                  Ovanesov, Mikhail V.
Subject:                          Information Request for 125446/0
 
Contacts:                        Kevin Smyth
 
Dear Mr. Smyth:
 
We are reviewing your August 28, 2012 biologics license application (BLA). We request that you make the following postmarketing commitment:
 
1.     Baxter commits to provide validation data to support the Precision (Repeatability and Intermediate Precision), Linearity and Range for the assay, Method No. –b(4)---------- used to determine the ----b(4)--------------------------------------- in RIXUBIS.  Baxter will apply an approach similar to that used for –b(4)----- determination in validation report      --b(4)------------------------ and will submit the final report to the FDA by 30 November 2013.
 
2.   Baxter commits to place at least one RIXUBIS lot on the stability program annually, rotating among different dose strengths.
 
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 June 5, 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.
 
The action due date for this file is tentatively June 30, 2013.
 
Please send an acknowledgement message for receipt of this request.
 
If you have any questions, please contact me at (301) 827-9167.
 
Sincerely,
 
 
Edward Thompson
Regulatory Project Manager

FDA/CBER/OBRR/DBA/RPMB