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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Employee Officer EDR Memo, September 11, 2013 - Q-Pan

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 

To:                              The File
Date:                          
 
BLA:                           STN 125419 September 11, 2013/0              
Sponsor:                      ID Biomedical Corporation of Quebec (dba GlaxoSmithKline Biologicals)
Product:                      Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
 
From:                          Carmen Collazo-Custodio, PhD
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.
 
Committee Member                                     Review Assignment
Carmen Collazo-Custodio                              Chair                                         
Jeremy Wally                                                 Lead RPM                                   
Kirk Prutzman                                                Co-RPM                                    
Hana Golding                                                 Product CMC                            
Surender Khurana                                           Product CMC                            
Nabil Al-Humadi                                            Toxicology                                 
Tielin Qin                                                       Assays Stats                              
Cheryl Hulme                                                 Lot Release                                                
Anthony Hawkins                                           BIMO                                        
Randa Melhem                                               Facilities/DMPQ                        
James Kenney                                                 Product Quality                        
Lokesh Bhattacharyya                                    Product Quality                        
Karen Campbell                                             Product Quality                        
David Schwab                                                 Electronic Integrity Review