Telecon Date/Time: 19 OCT 2011 Initiated by FDA? Yes
Telephone Number: -----(b)(4)-----
Communication Categorie(s): Information Request
Author: Tina Roecklein
Additional information to finish review
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.
- 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
- 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.