From:   Maruna, Thomas
Sent:   Tuesday, April 01, 2014 10:12 AM
To:   Daizadeh, Iraj (iraj_daizadeh@baxter.com)
Cc:   Ananyeva, Natalya; Bhattacharyya, Lokesh
Subject:   Information Requested: BLA 125512 Please Respond By April 10, 2014
Importance: High
Baxter Healthcare Corporation
Attention: Iraj Daizadeh, PhD
April 1, 2014
Sent by email
Dear Dr. Daizadeh:
We are reviewing your November 25, 2013 biologics license application (BLA) indicated for the treatment and prevention of bleeding episodes in patients with acquired inhibitory antibodies to human factor VIII (i.e., acquired hemophilia patients) for the following:
STN                Name of Biological Products
BL 125512     Antihemophilic Factor (Recombinant), Porcine Sequence
We determined that the following information is necessary to continue our review:
1. We requested documents TQC-004.04 for the chromogenic assay and 114102-SOP for the One Stage Coagulation Assay because you referenced these documents as the SOPs for the respective test method procedures in your corresponding method validation reports. Your latest version of the documents for these two assays, 061497-SOP and 061499-SOP, instead of the documents requested, are acceptable as test method SOPs. However, it raises the question about the nature and extent of the changes between the versions referenced in the validation reports and the current versions. This is important because you mentioned "procedure revisions" in your e-mail communication. We need to make an assessment whether the "procedure revisions" require complete or partial revalidation of the methods. Please provide the details of the changes between TQC-004.04 and 061497-SOP (chromogenic assay) and that between 114102-SOP and 061499-SOP (One Stage Coagulation Assay).
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 responses as an amendment to this file by April 10, 2014 referencing the date of this request.
If it is not feasible for Baxter to provide all responses by April 10th, please provide an alternative date to respond.
The action due date for these files is July 26, 2014.
If you have any questions, please contact me at (301) 827-6120.
Very Respectfully,
Thomas J. Maruna, MSc, MLS(ASCP)CM
Lieutenant, U.S. Public Health Service
Senior Regulatory Management Officer
Food and Drug Administration
CBER/OBRR/DBA/RPMB
1401 Rockville Pike
RM 562N, HFM-380 
Rockville, MD 20852
thomas.maruna@fda.hhs.gov
O: (301) 827-6120
BB: (240) 397-3419
www.usphs.gov
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