From:   Kumar, Vasantha
Sent:   Tuesday, December 24, 2013 1:27 PM
To:   'iraj_daizadeh@baxter.com'
Cc:   'linda_lemieux@baxter.com'; Maruna, Thomas
Subject:   BLA 125512/0 December 19th Information request
Importance: High
Hello Iraj,
I am writing on behalf of Thomas Maruna.
This is with reference to the information request that was sent you on December 19, 2013 and we have the following comment regarding that:
Considering the scope of the information requested in the 19 December 2013 Information Request for the original BLA 125512/0 for Antihemophilic Factor (Recombinant) Porcine Sequence, the Agency moves the due date for responses from 27 December 2013 to 8 January 2014. If you estimate that more time is needed to complete the responses, please notify the Agency immediately so that the new date can be negotiated.
Thanks
Vasantha
Vasantha Kumar, Ph.D.
U.S.Food & Drug Administration
CBER/OBRR/DBA/RPMB
WOC-1/Room 557N/HFM-380
1401 Rockville Pike
Rockville, MD 20852
Phone: 301-827-6142
Fax: 301-827-2857
E-Mail: vasantha.kumar@fda.hhs.gov
"THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please notify the sender immediately by e-mail or phone."

