Memo of Telecon - Cervarix, June 20, 2007

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

 

Memorandum

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Date:               June 20, 2007
To:                  STN BL125259.0
From:             Rebecca Olin, CBER/OCBQ/DMPQ/MRBII
Subject:          Memo of Telecon

 

Summary

On June 20, 2007, 3 pm EST, I telephoned Linda Kramer, Manager US Regulatory Affairs, to inform her of the DMPQ/OVRR decision regarding their request that they be allowed to use the data generated for Cervarix lot #---b(4)---------- in support of the process validation.  This lot had been filled on filling line -b(4)- located in Rixensart which will no longer be used for the Cervarix product.  I informed her that after discussions with Laurie Norwood, Dr. Chiang Syin, and BLA Chairperson Dr. Gopa Raychaudhuri that there were no objections to the data being used in support of the process validation for Cervarix.  I also instructed her to submit a letter as an Amendment to the BLA stating the line would no longer be used for Cervarix.  Ms. Kramer agreed to do so.  I also told her that since the removal of -b(4)-  was noted in the Kinrix BLA that no further action would be required for that file.  The conversation ended at approximately 3:15 pm.