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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Assay Reviewer Request Email, December 23, 2009 - MenHibrix

From: Cheung, Anissa
Sent: Wednesday, December 23, 2009 12:22 PM
To: Temenak, Joseph
Cc: Levis, Robin; Feinstone, Stephen
Subject: RE: Menhibrix (STN 125363 - orignal BLA) assay reviewer request
Steve Feinstone will review the Hepatitis B assay.

Thanks,
Anissa


From: Temenak, Joseph
Sent: Wednesday, December 23, 2009 10:28 AM
To: Levis, Robin; Cheung, Anissa; Krause, Philip; Rubin, Steven; Laassri, Majid; Lundquist, Ronald E.; Tang, Shuang
Subject: RE: Menhibrix (STN 125363 - orignal BLA) assay reviewer request
Robin (or Anissa),

Did you assign someone for the HBs (Hepatitis B) assay review?  If you did, could you please let me know who that is?  If it's here somewhere, I must have missed it.

Thanks,
Joe

Joseph J. Temenak, Ph.D.
Commander, U.S. Public Health Service
Director, Regulatory Review Officer
Bacterial Vaccines and Allergenic Products Branch
Division of Vaccines and Related Products Applications
OVRR\CBER\FDA
Tel: 301-827-3070
Fax: 301-827-3532
Email: joseph.temenak@fda.hhs.gov
Please note: my new e-mail address is joseph.temenak@fda.hhs.gov