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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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Committee Assignment, September 9, 2009 - MenHibrix

 

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.
 
Committee Members
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
RPMs/RC
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.
 
Thanks,
Jason
 
The link below should open the application in GS Review.
 
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