Record of Telephone Conversation, June 11, 2010 - MenHibrix

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: 301-827-5371

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.