Record of Telephone Conversation, January 26, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 26-Jan-2012 04:20 PM Initiated by FDA? No
1. Other – New Information from Sponsor
Author: TIMOTHY NELLE
GCP Violation During Lot Consistency Study (V58P9)
FDA Participants: TIMOTHY NELLE
Non-FDA Participants: KAIA AGARWAL
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
After reviewing the Optaflu BLA submission a second time, Novartis discovered that they neglected to submit the sensitivity analysis for excluding the one clinical trial site that experienced a GCP violation during the lot consistency study. They stated that the details of the GCP violation were provided in the original submission and that they had previously prepared the sensitivity analysis report but it was advertently omitted. However, before submitting this report, they preferred to review it again to ensure it was devoid of errors. They also stated that that this review would take approximately two weeks and then it would be submitted as an amendment to the BLA shortly thereafter.
Follow-up conversation with John P. Barry of Novartis on January 31, 2011, clarified that information about the GCP violation was not included in the BLA, as it was discovered after submission of the BLA. Dr. Barry also mentioned that the violation occurred at “Center 2” and accounted for 500 of the 1200 subjects in the lot consistency study ( V58P9); however, he could not comment on the exact nature of the GCP violation.