Officer/ Employee List for STN 125444/0, ALPROLIX

MEMORANDUM
 Public Health Service
Food and Drug Administration
 Center for Biologics Evaluation and Research

From: Edward Thompson, Regulatory Project Manager, DBA/OBRR

Re: Officer/ Employee List for STN 125444/0, ALPROLIX


Date: March 28, 2014

The following officers or employees of FDA participated in the decision to approve this application and consented to be identified on this list.
1.Nancy Kirschbaum - Chairperson/Product Reviewer
2.Nisha Jain - Clinical Reviewer
3.Stephanie Omokaro - Clinical Reviewer
4.Carl-Michael Staschen  Clinical Pharmacology
5.Xiang Li  Mathematical Statiscian
6.Ze Peng  Product Reviewer
7.Andrey Sarafanov  Product Reviewer
8.Anthony Hawkins - BIMO Reviewer
9.LaNissa Brown-Baker - Pharm/Tox Product Reviewer
10.Loan Nguyen - Labeling and Advertising Reviewer
11.Catherine Poole  Lot Release Coordination and QC Reviewer
12.Alfred Del Grosso - Lot Release Coordination and QC Reviewer
13.Ellen Huang, CMC/GMP/Facility Reviewer
14.Priscilla Pastrana, Facility/GMP/CMC Inspector
15.Jie He, Facility/GMP/CMC Inspector
16.Hsiaoling Wang, Confirmatory Testing and Quality Control
17.Igor Bacik, Confirmatory Testing and Quality Control
18.Edward Thompson - Regulatory Project Manager
