|DATE||December 16, 2008|
Christine Drabick, Bioresearch Monitoring Branch, HFM-664
Patricia Holobaugh, Bioresearch Monitoring Branch Chief, HFM-664
Laura Wood, HFM-340, Chair, BLA Committee
Bioresearch Monitoring Bioresearch Monitoring Inspection Results
The bioresearch monitoring inspections of three clinical sites did not reveal problems that impact the data submitted in the application.
Three clinical investigator inspections were performed in support of this Biologics License Application (BLA). Information from the BLA was compared to source documents during the inspections.
|Site #||# Subjects||483?||Inspection|
|New York Presbyterian Hospital|
New York, New York
|Children’s Memorial Hospital|
|Maine Hemophilia and|
Scarborough , Maine
STUDY TITLE: Pharmacokinetics of Haemocomplettan ® P in Subjects with Congenital Fibrinogen Deficiency (Study No. BI3023_2001)
At two of the three inspected sites, the amount of study drug remaining after administration to Subject -(b)(6)- (42 ml) and Subject -(b)(6)- (25 ml) exceeded the expected amount. Both sites state the dose administered to the subjects was correct and the study drug was prepared according to the protocol. Clarification from the sponsor regarding this finding may be required.
NOTE WORTHY INSPECTIONAL FINDINGS:
The following required laboratory evaluations were not completed for Subject -(b)(6)-: One-hour post infusion Gamma-glutamyl transpeptidase (GGT), Day 2 GGT, Pre-infusion Platelets, and Day 5 Biochemistry.
BIMO ADMINISTRATIVE FOLLOW-UP:
Close out letters have been issued to the clinical investigators at the three inspected sites. Should you have any questions or comments about the contents of this memo or any aspect of Bioresearch Monitoring, please contact me at 301-827-6323.
Christine J. Drabick, MS
Consumer Safety Officer