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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, March 6, 2013 - RIXUBIS

 

From:                              Thompson, Edward
Sent:                               Wednesday, March 06, 2013 9:15 AM
To:                                  Kevin Smyth (kevin_smyth@baxter.com)
Cc:                                  Ovanesov, Mikhail V.; Wang, Hsiaoling (Hsiaoling.Wang@fda.hhs.gov)
Subject:                          Information Request for BL 125446/0
 
Contacts:                        Kevin Smyth
 
Dear Mr. Smyth:
 
We are reviewing your August 28, 2012 biologics license application (BLA). We are providing the following comments and request for additional information to the -----b(4)-------------------------------------------------------------------- of recombinant products") assay to continue our review:
 
  1. Please provide the names, catalog number and manufacturer of the –b(4)-----------------------------------------------------------------
 
  1. Please send us the System Suitability Test (SST), in-house sample rFIX (described in 4.4.2) and control samples. Please attach the Certificate Of Analysis (COA) and established limit of the control sample.
 
  1. Please specify the established limits of the “working range” mentioned in 4.3.1 and 4.3.2 of the SOP.
 
  1. Please provide the acceptance criteria for the SST such as ---b(4)-----------------------------------------------------------------------
 
  1. Please provide the sample preparation procedure for the lyophilized control and sample. 
 
Please send above reagents to:
 
Dr. Hsiaoling Wang
Room B206
5516 Nicholson Lane
Kensington, MD 20895
 
The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this application. 
 
Please submit your response to this information request as an amendment to this file by March 21, 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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