• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Information Request Email, April 5, 2013 - Kcentra

From: Valencia, Iliana
Sent: Friday, April 05, 2013 5:42 PM
To: david.desris@cslbehring.com; ----------(b)(4)-------------
Cc: Walton, Beth; Valencia, Iliana
Subject: 125421: PMR Information Request
Attachments: BLA_125421 PMR Study Concept_04052013_v2.doc

Dear Dr. Desris:
We are reviewing your March 30, 2012 biologics license application (BLA) for Prothrombin
Complex Concentrate (Human). We determined that the following information is necessary to
continue our review:

       Attached is FDA Proposed BLA 125421 PMR Study Concept

Please submit your response to this information request as an amendment to this file by April 9,
2013 referencing the date of this request. If you anticipate you will not be able to respond by this
date, please contact me immediately so a new response date can be identified.

Sincerely,

Iliana on Beth Walton’s behalf.


Iliana Valencia, MS
Chief, Regulatory Project Management Branch
CBER/OBRR/IOD
301-827-6161
iliana.valencia@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 immediately notify the sender by e-mail or phone."