Information Request Letter2, April 11, 2011 - Kedbumin

Our STN: BL 125384/0

Kedrion, S.p.A
Attention: Mr. Urs E. Aeberli
FFF Enterprises, Inc.
April 11, 2011
Sent by email: uaeberli@fffenterprises.com

Dear Me. Aeberli:

We are reviewing your August 2, 2010 submission to your original BLA for Albumin (Human). We determined that the following information is necessary to continue our review 

Question 14. In assay validation reports for total protein determination, sodium caprylate, ---------------------(b)(4)--------------- rather than only citing "linearity, accuracy and precision.", please also provide validated ranges for each individual method, as was done for the sodium, and potassium ions determination for the drug product, Kedbumin (module 2.3.P summary table P.5-16).

Applicant’s response: 

Kedrion provides the amended Summary Tables P.5-10, P.5-27, P.5-30, P.5-32 and P.5.35 reporting the validated ranges (Attachment 5).

Additional question: Kedrion has provided validated ranges in the results column of the revised summary tables referred to above. Do the values stated for the application range in the results column of the amended summary tables represent the validated range for 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. If we determine that your response to this information request constitutes a major amendment, we will notify you in writing.

Please submit your response to this information request as an amendment to this file by April 18, 2011. If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified. The action due date for this file is June 3, 2011.

If you have any questions, please contact me at (301) 827-3927.

Sincerely,

 

Crystal Allard
Regulatory Project Manager
FDA/CBER/OBRR/DBA/RPMB
