
Employee Officer List Memo - Flucelvax

 

EMPLOYEE/OFFICER LIST MEMO

 


To:                              The File

Date:                           October 18, 2012

 

BLA:                           STN 125408                

Sponsor:

Product:                      [FLUCELVAX, Influenza Virus Vaccine]

 

From:                          [Timothy Nelle, Ph.D.]

Signature:                   

 

 

 

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

 
