Record of Telephone Conversation, October 19, 2011 - MenHibrix

Product:  MenHibrix

Manufacturer:   GSK          

Telecon Date/Time:  19 OCT 2011           Initiated by FDA?  Yes
Telephone Number: -----(b)(4)-----

Communication Categorie(s): Information Request

Author:  Tina Roecklein

Telecon Summary:
Additional information to finish review

FDA Participants:  
Tina Roecklein

Non-FDA Participants:   

Jody Gould

Telecon Body:

GSK submitted their response to our 11 June 2010 CR letter on 15 April 2011.  A second CR letter was sent to GSK on 22 September 2011.  Two items were noted during the review that did not meet the criteria for inclusion in the CR letter.  I called the firm to request the additional information below.

1. The updated validation report for the MenY SBA dated August 2010 has a “confidential” watermark that obscures part of every page.  Please submit a clean copy of the report for review.
   
   Report Name:  Measurement of bactericidal activity of human serum antibodies to Neisseria meningitidis Serogroup Y in presence of human complement
   
   Edition date:  August 2010
   
   No. Code:  2009-V-008-R
   
    
2. Figure 5 on page 19 of the CR response dated 15 April 2011 for Question 38 is a graph of Linearity for ---(b)(4)--- and ---(b)(4)--- Content.  These tests are plotted on the same graph and the resultant ---(b)(4)--- Plot encompasses the entire graph while the ---(b)(4)--- line is only a small portion of the graph.  Please replot the ---(b)(4)--- data so that the line will use the entire graph so that any possible trends could be detected.