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Kedrion Original BLA, September 10, 2010 - Kedbumin

From: Ortega, Lillian
Sent: Friday, September 10, 2010 9:59 AM
To: Allard, Crystal
Cc: Landow, Laurence
Subject: Kedrion Original BLA - 125384/0

 
Hello Crystal,
 
Based on my review of the BLA submission and discussions held at the first committee meeting August 25, 2010, this BLA does not contain new clinical trial data that would require Bioresearch Monitoring inspections at this time. The removal of BIMO from the review team is usually confirmed by the clinical reviewer or committee chair when it is determined that BIMO inspections are not needed. BIMO reviewers can stay on the review committee just in case something comes up during the review process requiring an inspection.  
 
Please let me know if there are any questions.
Lillian Ortega

Consumer Safety Officer
Division of Inspections and Surveillance
Bioresearch Monitoring Branch (HFM-664)
FDA/CBER/Office of Compliance and Biologics Quality
(301) 827-6335
fax (301) 827-6748
lillian.ortega@fda.hhs.gov