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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Officer Employee List, April 29, 2013 - Kcentra

Memoramdum                                                                                                                           Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research


From:        Beth Walton, MBA, PMP, Regulatory Project Manager, DBA/OBRR
 
Re:            Officer/ Employee List forSTN 125421/0, Kcentra, Prothrombin Complex
 
Date:         April 29, 2013
                
 
The following officers or employees of FDA participated in the decision to approve this application and consented to be identified on this list.
 
 
1. Ze Peng, Chairperson, DH, CMC
2. Beth Walton, DBA, RPMB
3. La'Nissa Brown, DH, Pharm/Tox
4. Iftekhar Mahmood, DH, Clinical Pharmacology
5. Roman Drews, DH, CMC
6. Leland Ross Pierce, DH, Clinical
7. Lokesh Bhattacharyya, DBSQC, Lot Release Testing and Protocol Review
8. Anthony Hawkins, DIS, BIMO
9. Jiang (Jessica) Hu, DB, Biostatistics
11. Rebecca Olin, DMPQ, CMC, Facility
12. Sukhminder Sandhu, DE, Epidemiology
13. Catherine Poole, DBSQC, Lot Release Testing and Protocol Review
14. Alfred Del-Grosso, DBSQC, Lot Release Testing and Protocol Review
15. Igor Bacik, DBSQC, Lot Release Testing and Protocol review