
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

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