Mid-Cycle Review Memo, January 26, 2010 - MenHibrix

DATE	January 26, 2010
FROM	Robert Wesley, Bioresearch Monitoring, HFM-664 Division of Inspections and Surveillance Office of Compliance and Biologics Quality
THROUGH	Patricia Holobaugh, BIMO Branch Chief, HFM-664
TO	Joseph Temenak, Ph.D., HFM-481, Chair Jason Humbert, HFM-481, RPM
SUBJECT	Mid-Cycle Review Memo Sponsor: GlaxsoSmithKline Product: MenHibrix [Meningococcal Groups C and Y and Haemophilus B Tetanus Toxoid Conjugate Vaccine] BLA/STN: 125363/0

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MIDCYCLE REVIEW SUMMARY

Assignments for three clinical investigators were issued on November 9, 2009, with a requested due date of February 15, 2010.  As of January 25, 2010, all inspections assignments have been assigned, but none of the inspections have been begun.

A serology testing laboratory assignment was issued on December 11, 2009 with a requested completion date of April 19, 2010.  That inspection request has not been assigned to a District/Investigator at this time.

The BLA committee will be apprised of any significant deviations noted during the inspections.  A final BLA review summary statement will be prepared following submission and review of all inspection reports.

 

 

Robert Wesley
Consumer Safety Officer