Bioresearch Monitoring BLA Summary Report - Wilate, December 13, 2007
|DATE||December 13, 2007|
|FROM||Solomon Yimam, Bioresearch Monitoring Branch, HFM-664|
Division of Inspections and Surveillance
Office of Compliance and Biologics Quality
|SUBJECT||Bioresearch Monitoring BLA Summary Report|
CH-8852 Lachen, Switzerland
|PRODUCT||WILATE is a human plasma-derived, stable, high purity, double virus inactivated concentrate of freeze-dried FVIII and VWF. It is prepared using cryoprecipitate harvested from plasma collected in the U.S. WILATE is supplied as a powder for reconstitution and intravenous injection.|
Bioresearch Monitoring Branch Chief, HFM 664
|TO||Timothy Lee, HFM-392|
Chair, BLA/STN 125251
FINAL SUMMARY STATEMENT
Results of three bioresearch monitoring inspections of three clinical sites did not reveal problems that impact the data submitted in the application.
Inspections of three clinical investigators were performed in support of this Biologics License Application (BLA). Information from the BLA was compared to source documents during the inspections. The inspections focused on specific questions concerning the study.
STUDY TITLE: A Prospective, Randomized, Controlled, Open-labeled, Two-arm Crossover Study Investigating the Pharmacokinetic Properties of WILATE and Humate-P® in Subjects with Inherited von Willebrand Disease (WIL-12).
The clinical investigator inspections assigned included the following:
|Clinical Investigator||Study Site||Location||FDA 483||Final Classification|
|Jerry S. Powell, MD||University of California at Davis|
Hemophilia Treatment Center
|Arthur R. Thompson, MD, PhD||Puget Sound Blood Center||Seattle, Washington||NO||NAI|
|Jorge DiPaolo, MD||University of Iowa|
Hospitals & Clinics
Department of Pediatrics
|Iowa City, Iowa||NO||NAI|
The inspections of the three clinical investigators did not reveal any significant protocol deviations.
BIMO ADMINISTRATIVE FOLLOW-UP
Close out letters were issued to Dr. Jerry S. Powell, Dr. Arthur R. Thompson, and Dr. Jorge DiPaolo.
Should you have any questions or comments about the contents of this memorandum or any aspect of Bioresearch Monitoring, please contact me at (301) 827-1948.
Consumer Safety Officer