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Status of Bioresearch Monitoring Inspections - Atryn




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Memorandum

Date: September 30, 2008 

From: Joseph P. Manik, Bioresearch Monitoring, HFM-664
 Division of Inspections and Surveillance
 Office of Compliance and Biologics Quality 

Through: Patricia A. Holobaugh
 Bioresearch Monitoring Branch Chief, HFM-664 

To: Roman T. Drews, Ph.D., Committee Chair, HFM-392
 Pratibha Rana, Regulatory Project Manager, HFM 380 

Subject: 

Midcycle Review
 Status of Bioresearch Monitoring Inspections
SPONSOR: GTC Biotherapeutics, Inc.
 PRODUCT: ATryn ® (antithrombin alfa rhAT)
 BLA: STN 125284/0

Review Status:

The following four clinical investigator inspection assignments were issued on 
September 8, 2008. The inspections are pending and a review will be conducted 
after the completion of the inspections and the receipt of the inspection 
reports.

Clinical investigators:

Michael Paidas, M.D. Center 01-06 (1 subject)
Yale-New Haven Hospital
 Department of OBGYN and Reproductive Sciences
 333 Cedar Street
 FMB 308
 New Haven , Connecticut 05620 -8063
 Telephone: (203) 737-1982

Maria DeSancho, M.D. Center 01-04 (1 subject)
Weill Medical College of Cornell University
 Weill Cornell Medical Center
 520 East 70 th Street
 Suite 341
 New York , New York 10021
 Telephone: (212) 746-9051

Don W. Shaffer II, M.D., F.A.C.P. Center 81 (2 subjects)
Northwest Georgia Oncology Centers
 340 Kennestone Hospital Boulevard, Suite 200
 Marietta , Georgia 30060
 Telephone: (770) 281-5100

John Lazarchick, M.D. Center 83 (1 subject)
Children’s Hospital
 Medical University of South Carolina
 165 Ashley Avenue
 Department of Pathology and Laboratory Medicine
 Suite 309
 Charleston , South Carolina 27425
 Telephone: (843) 792-3424

Should you have any questions or comments about the contents of this memorandum 
or any aspect of Bioresearch Monitoring, please contact me at (301) 827-6335.

___________________________
 Jospeh P. Manik
 Consumer Safety Officer
 

   
 


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