Information Request, April 14, 2014 - Eloctate

From: Pracht, Leigh
Sent: Wednesday, April 16, 2014 10:00 AM
To: Debra Segal
Cc: Elijah Tan (elijah.tan@biogenidec.com)
Subject: STN 125487.0 Information Request/Follow up to April 14, 2014 inquiry

Importance: High

Our Reference: BL 125487/0

Biogen Idec Inc.
Attention: Ms. Debra Segal
April 16, 2014
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 your acknowledgement to continue our review:

1. In response to Agency request at mid-cycle (item #23), Biogen committed to submitting a prior approval supplement (PAS) for a one time exception in the event Biogen sought to release a lot manufactured outside critical limits, including excursions to: (1) in-process specifications, (2) maximum processing times/ process intermediate hold times, (3) any parameter controlling viral inactivation by –b(4)------------------------------------------------------------ (4) any parameter controlling virus removal by –b(4)---- 15N filtration and (5) critical control parameters for the production –b(4)-------------- chromatography steps, sterile filtration, lyophilization or diluent –b(4)--- sterilization. Please be advised that the Agency has reconsidered this and no longer requests post-marketing submission of supplements under these circumstances. We expect that Biogen Idec will comply with the current good manufacturing practice requirements in section 501(a)(2)(b) of the Federal Food, Drug and Cosmetic Act and Title 21 Code of Federal Regulations parts 210 and 211, including those related to the quality unit. We will review your firm’s actions during post-market inspections of your facilities.

2. Please respond in writing that you acknowledge this communication.

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 by April 18, 2014 referencing the date of this request.

The action due date for this file is June 7, 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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