From: Valencia, Iliana
Sent: Friday, April 05, 2013 5:42 PM
To: firstname.lastname@example.org; ----------(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.
Iliana on Beth Walton’s behalf.
Iliana Valencia, MS
Chief, Regulatory Project Management Branch
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