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Vaccines, Blood & Biologics

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Vaccines

Record of Email Communication, February 25, 2010 - 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: 25-Feb-2010 09:54 AM Initiated by FDA? No
Telephone Number: Communication Categorie(s):
1. Other - Confirmation that requested –b(4)---- for testing received by CBER

Author: JASON HUMBERT Telecon Summary:
CBER has received the requested ---b(4)--- for testing

FDA Participants: Alfred V. Del Grosso, Karen Campbell, Rajesh Gupta, Jason Humbert

Non-FDA Participants: Norris Pyle

Telecon Body:
Norris,

We received the –b(4)--- earlier this week. Thanks very much for your assistance with this. Al Del Grosso
Alfred V. Del Grosso, Ph.D. Analytical Chemistry Staff Division of Product Quality FDA-CBER-OVRR
Phone 301-435-4988
Fax 301-435-4991

From: norris.h.pyle@gsk.com [mailto:norris.h.pyle@gsk.com]
Sent: Thursday, February 25, 2010 9:50 AM
To: Campbell, Karen M
Cc: Del-Grosso, Alfred; Humbert, Jason (CBER); Gupta, Rajesh
Subject: Re: MenHibrix (STN 125363): --b(4)----for testing

Hi Karen,
Just following up to make sure you have received the –b(4)----. Let me know. Thank you - Norris