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Vaccines, Blood & Biologics

Status of Bioresearch Monitoring Inspections - Atryn


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


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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