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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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Review Committee Assignment Memorandum, May 2, 2011 - MenHibrix

 

Date:              May 2, 2011
 
To:                  125363/12 File
Review Committee
 
From:             David C. Staten, MPH, CDR, USPHS
 
Thru:             Joseph Temenak, Ph.D.
Chair, MenHibirx Review Committee Assignment Memo
 
Subject:         Review Committee Assignment
 
The following committee members has been assigned to GSK’s CR response for MenHibrix
(Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine). The action due date for this application is October 15, 2011
Review Assignment              Committee Member                         Supervisor
Chair                                       Joseph Temenak.                    Elizabeth Sutkowski
RPM                                       David Staten,                          Elizabeth Sutkowski
                                             Kirk Prutzman                        Elizabeth Sutkowski
 
Clinical Reviewer                   Meghan Ferris                        Lucia Lee
Product CMC/Serology          Mustafa Akkoyunlu               Willie Vann
Product CMC                         Willie Vann                            Jay Slater
Product CMC                         Daron Freedberg                    Willie Vann
Product CMC                         Drusilla L Burns                     Jay Slater
Product CMC                         Annisa Cheung
Product CMC                         James E Keller                       Drusilla Burns
Product CMC                         Majid Laassri                         Konstantin Chumakov
Product CMC                         Steven A Rubin                      Konstantin Chumakov
Product CMC                         Michael Schmitt
Product CMC                         Shuang Tang                          Philip Krause
Product CMC                         Iryna Zubkova                        Iryna Zublova
Toxicology                             Steven C Kunder                    David Green
 
Product CMC                         Tina Roecklein                       Jay Slater
Facilities/DMPQ                    Sean Byrd                               Carolyn Renshaw
Advertising/
Promotional Labeling             Maryann Gallagher                Lisa Stockbridge
Clinical Statistical Reviewer  Barbara Kransnicka                Massie, Tammy
Assays Statistical Reviewer  Tsai-Lien Lin                         Dale Horne
Epidemiology                         Manette Niu                           Thomas Buttolph
DPQ/Lot Testing Plan            Rajesh Gupta                          Bill McCormick
DPQ/Lot Testing Plan            Karen Campbell                     Bill McCormick
Lot Release                              Joe Quander                            Jay Elterman
BiMo                                        Soloman Yimam                      Patricia Holobaugh
 Electronic Integrity Review     David Schwab               Laraine Henchal
 
 
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