10/20/2008 Telecon - RiaSTAP
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID:125317/0 Office: OBRR
Human Fibrinogen Concentrate, Pasteurized
CSL Behring GmbH
Telecon Date/Time: 20-OCT-2008 12:00 AM Initiated by FDA? Yes
Author: VASANTHA KUMAR
FDA Participants: Nisha Jain, Jennifer Scharpf, Don Jehn, Laura Wood, Vasantha Kumar
Non-FDA Participants: Paul Hartman and Maureen Morgan
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
This telecon was to discuss the options and the route CSLB wanted to take for the BPAC meeting on 9 January 2009. CSLB wanted to find out the level of detail that would be discussed in the BPAC meeting since this was an accelerated approval with a PMR study.
They were informed by CBER that only limited information was needed. The Phase 4 study will need to be presented because of the need for validation of the surrogate endpoint validation used in the licensure study.
It was proposed that during the BPAC meeting, CSLB and FDA would present:
- MCF study
- General discussion
- Synopsis and outline of Phase IV studies
With the above plan, CSLB agreed that there would be no need for a closed session for the BPAC.