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Vaccines, Blood & Biologics
Date: 9 September 2009
To: Review Committee, STN 125363/0 (Revised)
From: Jason Humbert
Thru: Joseph Temenak, Ph.D.
Chair, MenHibrix Review Committee
Subject: Committee Assignment, MenHibrix BLA STN 125363/0
The following committee has been assigned to GSK’s electronic BLA for MenHibrix™ [Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine]
The action due date for this application is June 12, 2010.
Chair Joseph Temenak, Ph.D.
Clinical Reviewer/Labeling Meghan Ferris, M.D.
Product CMC/Serology Mustafa Akkoyunlu, M.D. Ph.D,
Product CMC Willie Vann, Ph.D.
Product CMC Daron Freedberg, Ph.D
Product CMC Milan Blake, Ph.D.
Product/CMC Tina Roecklein, MS
Product/CMC James (Erich) Keller, Ph.D.
Product/CMC Michael Schmitt, Ph.D.
Facilities/DMPQ Joseph George
Facilities/DMPQ Sean Byrd
Advertising/ Promotional Labeling Maryann Gallagher
Clinical Statistical Reviewer Barbara Krasnicka, Ph.D.
Assays Statistical Reviewer Tsai-Lien Lin, Ph.D.
Epidemiology David Menschik, M.D., MPH
DPQ/Lot Testing Plan Rajesh Gupta, Ph.D.
DPQ/Lot Testing Plan Karen Campbell
Lot Release Joe Quander III
BiMo Robert Wesley
Electronic Integrity Reviewer David Schwab, MSIS
DVRPA Regulatory Project Manager Jason Humbert
DVRPA Regulatory Project Manager David Staten, MPH
DBPAP Regulatory Coordinator Jennifer Bridgewater, MPH
Any revisions to the review committee will be sent out via email.
A review schedule with timelines and due dates will be issued within the next few days. This is an electronic submission. The electronic link to the eBLA is attached below. Please access the file using the link below. If the link does not work, you may also access the BLA directly through the EDR. If you have any difficulties accessing the submission please contact the ERIC help desk.
The link below should open the application in GS Review.