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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Employee Officer List Memo - Flucelvax

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
To:                              The File
Date:                           October 18, 2012
BLA:                           STN 125408               
Product:                      [FLUCELVAX, Influenza Virus Vaccine]
From:                          [Timothy Nelle, Ph.D.]
Section 916 of the Food and Drug Administration Amendments Act (FDAAA) requires that the identity of each employee or officer who participated in the decision to approve an original application be listed and filed as part of the Action Package for that file.
The following employees and officers have consented to have their names published publicly as being a participant in the approval decision for this file.
NAME                                    ROLE
Timothy Nelle, Ph.D.             Chair
Melisse Baylor, M.D.             Clinical Reviewer
Nabil Al-Humadi, Ph.D.         Toxicology Reviewer
Tammy Massie, Ph.D.           Statistical Reviewer, Clinical
Scott Winiecki, M.D.             Epidemiology Reviewer
Lihan Yan, Ph.D.                  Statistical Reviewer, Bioassay
Rajesh Gupta, Ph.D.             CMC Reviewer, Analytical Methods
Karen Campbell                    Lot Release
Lokesh Bhattacharyya            Lot Release
Zhiping Ye, Ph.D.                  Product Reviewer
Anissa Cheung, MSc.             Product Specialist
Haruhiko Murata                    Product Reviewer
Xianghong Jing                      Product Reviewer
Pankaj Amin                          Facility Reviewer
Ellen Huang                           Facility Reviewer
Anthony Hawkins                   Bioresearch Monitoring Reviewer
LT David Schwab, MSIS        Electronic Integrity Reviewer
Timothy Fritz, Ph.D.              Regulatory Project Manager