Information Request, August 29, 2013- Eloctate

From: Pracht, Leigh
Sent: Thursday, August 29, 2013 11:49 AM
To: Debra Segal
Subject: Information Request STN 125487/0 -b(4)-- assay August 29, 2013

Importance: High

Our Reference: BL 125487/0

Biogen Idec Inc.
Attention: Ms. Debra Segal
August 29, 2013
Sent by email

Dear Ms. Segal:

We are reviewing your March 7, 2013 biologics license application (BLA) for Antihemophilic Factor (Recombinant), Fc Fusion protein. We are providing these comments and request for additional information to continue our review:

1. The responses to the IR of the “—-b(4)-------------------------------------------------------------------------- in amendment 0.12 (submitted on August 7, 2013) have been reviewed.

    DBQSC doesn’t agree that limits on the content of –b(4)--- in the control sample are appropriate criteria for column performance check. The acceptance criterion of –b(4)-- for the control only provides a characteristic attribute of the material.

    DBSQC understands that when the –b(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Please update the SOP accordingly and submit together with supportive data for review.

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 September 12, 2013, referencing the date of this request.

The action due date for this file is March 8, 2014.

If you have any questions, please contact me at (301) 827-6116.

Best regards,

Leigh A. Pracht
Regulatory Project Manager
FDA/CBER/OBRR/DBA
WOC1; RM562N; HFM-380
1401 Rockville Pike
Rockville, MD 20852
Telephone: 301-827-6116
Fax: 301- 827-2857
Leigh.Pracht@fda.hhs.gov

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