Food and Drug Administration, Center for Biologics Evaluation and Research
Office of Vaccines Research and Review Division of Vaccines and Related Product Applications Bacterial Products Department, HFM-481
TELEPHONE CONVERSATION RECORD
DATE: JUNE 11, 2010
TIME: 2:00 PM
CBER REP’S: JOSEPH TEMENAK
ORGANIZATION/ REP’S: GSK Biologicals, S.A. – Jody Gould
TELEPHONE NO: ------(b)(4)------
SUBJECT: GSK was informed that their original BLA submission for MenHibrix will receive a Completer Response (CR letter) prior to the action date for the submission June 12, 2010. The telecon was initiated by FDA.
Reference Number: BLA (original) 125363
SUMMARY OF DISCUSSION:
The discussion with GSK was initiated to inform them that FDA would issue a Complete
Response (CR) letter to the MenHibrix BLA.