
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 


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
