
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