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Vaccines, Blood & Biologics

Bioresearch Monitoring "Mid-Cycle" Review Report - RECOTHROM


Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research

DATE: June 12, 2007

FROM: Janet White, Bioresearch Monitoring, HFM-664
Division of Inspections and Surveillance
Office of Compliance and Biologics Quality

THROUGH: Patricia Holobaugh, Bioresearch Monitoring Branch Chief, HFM 664

TO: Roman Drews, HFM-392, Chair, BLA Committee

SUBJECT: Bioresearch Monitoring "Mid-Cycle" Review Report
BLA/STN 125248/0
Product: Recombinant Human Thrombin (rhThrombin)
Sponsor: ZymoGenetics, Inc., Inc.

Three clinical investigator inspection assignments were issued on February 22, 2007. The BIMO Inspection assignment included specific questions for the following protocol: 499E01 - A Phase 3, Randomized, Double-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Recombinant Human Thrombin (rhThrombin) and Thrombin-JMI (Bovine Thrombin) in Surgical Hemostasis. The assignments included instructions to compare data from the BLA and the source documents.

Yuri S. Genyk, M.D.
USC Healthcare Consultation Center
Los Angeles, California
James W. McNeil, M.D.
Vascular Surgery Associates
Baton Rouge, Louisiana
Kenneth L. Renkens Jr., M.
Indiana Spine Group
Indianapolis, Indiana


The preliminary inspectional finding for Dr. Renkens' site included the following one FDA-483 item: failure to conduct the investigation in accordance to the investigational plan. This finding involved baseline conditions, adverse events, and concomitant medications that were noted in the subject study files and nmedical records, but which were not included on the case report forms or included in the study data reported to the FDA by the sponsor.

It should be noted that the above finding for Dr. Renkens is soley from the FDA-483 issued and has not been verified by the BIMO branch through review of the inspection report and exhibits. BIMO has not reviewed the inspection report and exhibits for Dr. McNeil.

BIMO issued an NAI letter to Dr. Guy Young.

Should you have any questions or comments about this memorandum or any aspect of Bioresearch Monitoring, please contact me at (301) 827-1948.

/Janet White/
Janet White
Consumer Safety Officer


Paper Copies
HFM-99 File Copy
HFM-664 White
HFM-664 Access/Chron

Scanned E-mail Copy (FYI)

HFM-650 Gilliam Conley
HFM-392 Roman Drews
HFM-380 Mark Shields
HFM-392 Nisha Jain

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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