
Information Request, October 9, 2013 - Eloctate


 
 
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

Food and Drug Administration 1401 Rockville Pike
 Rockville, MD 20852-1448


 

Our Reference:  BL 125487/0

Biogen Idec Inc.
 Attention:  Ms. Debra Segal
 October 9, 2013
 Sent by email

Dear Ms. Segal:

We are reviewing your August 7, Quality Information Amendment submitted as Amendment 12 of STN 125487/0.  We are providing these comments and request for additional information to continue our review:
1.We do not agree with your reason for not performing linearity study for Calcium Content by --–b(4)----- in the product matrix.  Please provide appropriate data to demonstrate linearity of the procedure in the product matrix over the proposed range of the 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 response by October 23, 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.

Sincerely,

Leigh Pracht
 Regulatory Project Manager
 FDA/CBER/OBRR/DBA/RPMB
