Record of Telephone Conversation, May 3, 2012 - 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: 03-May-2012 12:30 PM Initiated by FDA? Yes

Telephone Number: ----b(4)----------

Communication Categorie(s):
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary:
Tcon to discuss the 5/2/2012 IR sent to GSK

FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK, DAVID STATEN, TINA ROECKLEIN

Non-FDA Participants: Jody Gould, Norris Pyle

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

CBER and GSK met to follow up on the earlier, 10:00 am 5/3/2012 tcon to follow up on several items.

CBER confirmed that release and stability testing should be conducted on MenHibrix reconstituted in saline and confirmed that GSK can use the current specifications with -b(4)--- to run their tests. Any changes in test specifications that result from changing to saline diluent should be submitted as a Prior Approval Supplement after approval. CBER also confirmed that change to saline will not require re-validation. CBER reiterated that the lot number and expiry should be printed on the carton and not on a sticker.

Call ended