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Vaccines

Follow-up Discussion on GSK’s October Meeting Minutes, November 19, 2010 - MenHibrix

RECORD OF TELEPHONE CONFERENCE

STN: 125363/0
 
Date: November 19, 2010
 
From: David C. Staten, Jr, MPH, CDR, USPHS
 
Subject: Follow-up discussion on GSK’s October meeting minutes and CR issues related to the free polysaccharide content
 
Summary: FDA clarified that the current data regarding the free polysaccharide content is not sufficient to address the CR comments. FDA requested additional data on the failed assays. FDA suggested that these data be submitted in advance of receiving the sponsor’s CR response. FDA suggested that the data be submitted to the sponsor’s IND and agreed to review the data in 60 days.