• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu

Vaccines

Committee Assignment, August 25, 2009 - MenHibrix

Date:                              25 August 2009

To:                                 Review Committee, STN 125363/0

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 Review/LabelingMeghan Ferris, M.D.
Product CMC/SerologyMustafa Akkoyunlu, M.D. Ph.D, 
Product CMCWillie Vann, Ph.D.
Product CMC                                                      Daron Freedberg, Ph.D
Product CMC                                                       Milan Blake, Ph.D. 

Product/CMC                                                      
Tina Roecklein, MS
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


RPMs/RC
DVRPA Regulatory Project Manager              Jason Humbert
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.

-------------------------(b)(4)-------------------------------------