Record of Telephone Conversation, September 21, 2011 - MenHibrix

Submission Type: BLA    Submission ID: 125363/0    Office: OVRR
Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Applicant:
GlaxoSmithKline Biologicals
Telecon Date/Time: 21-Sep-2011 04:00 PM        Initiated by FDA? Yes
Telephone Number: ------(b)(4)---------
Communication Categorie(s):
1. Advice

Author: KIRK PRUTZMAN
Telecon Summary:
Notify sponsor of issuance of a CR-Letter
FDA Participants: JODY GOULD
Non-FDA Participants: KIRK PRUTZMAN, DAVID STATEN, JOSEPH TEMENAK
Trans-BLA Group: No

Related STNs: None
Related PMCs: None
Telecon Body:

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.