
Record of Telephone Conversation, February 15, 2012 - Flucelvax

 
 

Date/Time of Call:                             February 15, 2012 @ 11 AM

 

CBER Representative:                    

Pete Amin, Reviewer, CBER/OCBQ/DMPQ/MRBII

Marion Michaelis, Team Leader, CBERR/OCBQ/DMPQ/MRBII

Ellen Huang, CSO, CBER/OCBQ/DMPQ/MRBII

 

Organization Representative:          

John Berry, Head of Regulatory Affairs, Novartis Vaccines and Diagnostics, Inc.

Umang Shah, Regulatory Affairs CMC, Novartis Vaccines and Diagnostics, Inc.

 

Organization:                                    Novartis Vaccines and Diagnostics

                                                            

Telephone:                                         ------------(b)(4)-----------------------------

 

Subject:                                              BLA STN 125408/0, Holly Springs

 

STN:                                                   STN 125408/0

                        

 

We contacted Novartis to discuss the Holly Springs, NC facility. Novartis stated that the Holly Springs facility will be doing testing and warehousing. The final product will be shipped to Holly Springs from (b)(4) or Marburg. The firm also stated that they will be submitting a validation report for a new SRID method (parallel line) for the monovalent and --------(b)(4)-------- as an amendment.

 

Novartis also explained to us their future plans for Holly Springs including --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.