Submission Type: BLA Submission ID: 125392/0 Office: OBRR
Telecon Date/Time: 24-May-2012 10:00 AM Initiated by FDA? Yes
Telephone Number: —b(4)---------------
1. Information Request
Author: TRACY TILGHMAN
Purpose of teleconference: to discuss the submission of the integrated safety summary tables (i.e. sas data tabulation sets, for studies 400-07-002, 400-08-002 and 400-10-001).
Kimberly Lindsey, M.D., Medical Officer, OBRR/DH
Tracy Tilghman, MPH, Consumer Safety Officer, OBRR/DBA
Raina Dauria, Group Director Regulatory Affairs, Ethicon, Inc.
Jessica Shen, Group Director Clinical Development, Ethicon, Inc.
Jonathan Batiller, Associate Director Clinical Development, Ethicon, Inc.
Jerome Riebman, Medical Director, Ethicon, Inc.
Bob Patel, Director Biostatistics, Ethicon, Inc.
Samson Tom, Director R&D, Ethicon, Inc.
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
The purpose of this conference call was to discuss the integrated SAS data sets that were requested by the clinical reviewer (Dr. Kimberly Lindsey). The clinical reviewer stated that Ethicon originally provided individual data sets for studies 400-07-002 and 400-08-002 previously, but that the integrated datasets were needed to assess the safety studies for the pivotal trial (adjunct to hemostasis in hepatic resection , study 400-10-001) done outside the United States. The studies in question include studies 400-07-002 (US soft tissue surgery study), 400-008-002 (ex. US soft tissue surgery study) and 400-10-001 (ex US hepatic resection study). Ethicon stated that they submitted the three study datasets to the Regulatory Project Manager, who would review the submitted information and notify the company if there are any discrepancies. Once the datasets are approved, Ethicon will formally submit the information to be included in the submission.