Information Request, June 18, 2013- Eloctate

 
From: Pracht, Leigh
Sent: Tuesday, June 18, 2013 12:26 PM
To: Debra Segal
Subject: IR STN 125487/0 18-Jun-13
 Our Reference:  BL 125487/0

Biogen Idec Inc.
 Attention:  Ms. Debra Segal
 June 18, 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 determined that the following information is necessary to continue our review:
1.You have not validated the Chromogenic Potency Assay citing that it is a compendial procedure, taken from ---b(4)---------------------------.  We do not consider those assays cited in –b(4)----------------------- as compendial assays.  Furthermore, the criticality of a potency assay precludes its consideration without appropriate method validation.  Please validate this assay for –b(4)---------------------- the drug product, and submit the validation report.
2. Please provide SOPs for the following tests:
•Chromogenic Potency Assay
•---b(4)------------------------------------------------------------------
•---b(4)-----------------------------------------------

The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission.

If the validation has not been performed, please submit your response to item #1 as an amendment to this file by July 26, 2013; if the validation is complete, please submit responses to both requests by July 9, 2013 referencing the date of this request.  Regardless of the validation, we request a response to item #2 by July 9, 2013.

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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