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Vaccines, Blood & Biologics

Committee Filing Meeting, September 21, 2009 - MenHibr

Date:   September 21, 2009


Application Recieved:August 12, 2009
Committee Assignment  August 25, 2009
1st Committee Meeting    September 8, 2009
Filing Meeting      September 25, 2009 (via e-mail)
Filing Action/Deficiencies Identified     October 11, 2009
Action Due Date:     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



DVRPA Regulatory Project Manager

   Jason Humbert

DVRPA Regulatory Project Manager 
David Staten, MPH
DBPAP Regulatory Coordinator Jennifer Bridgewater, MPH

Summary: An e-mail was sent to review committee members asking whether the BLA may be filed and whether any deficiencies have been identified that should be included in the filing notification letter. The unanimous response from the committee was that the BLA should be filed. The clinical reviewer indicated that several deficiencies have been identified and those letter-ready comments will be made available before the filing notification letter is drafted.

No other issues were raised. A filing notification letter will be issued on or before October 11, 2009. A mid-cycle meeting has been scheduled for January 12, 2010.

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