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Vaccines, Blood & Biologics

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Vaccines

Telephone Conference Amendment Review Memorandum, June 21, 2010 - MenHibrix

 

Date:               June 21, 2010 1231 PM
 
To:                  STN 125363 FDA Regulatory File
 
From:              David C. Staten, Jr., MPH, CDR, USPHS
                        BLA Regulatory Project Manager
 
Subject:           Record of FDA and GlaxoSmithKline June 21, 2010 Telephone Conference
 
Summary:        GSK called in inquire if FDA will review their June 4, 2010 amendment which included clinical serology data for the Men Y assay. These data were originally requested by FDA back in Fedruary and receipt of the submission was acknowledged in the June 11, 2010 CR letter. The sponsor also requested to respond to CR issues in piecemeal submissions.
 
Action:            After discussions with the review team it was agreed that the June 4, 2010 amendment will not be reviewed until the sponsor responds to all CR issues. The responses will be submitted as one submission and not by piecemeal submissions. This was conveyed to the sponsor via telecon on June 23, 2010 1430.