11/07/2008 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: 07-NOV-2008 12:00 AM Initiated by FDA? Yes
Author: VASANTHA KUMAR
FDA Participants: Craig Zindermann. Nisha Jain, Vasantha Kumar
Non-FDA Participants: David Desris, Paul Hartman, Patricia
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
CSLB wanted to clarify the following:
- these post-market actions are acceptable and
- if the PV plan we submit is found to be acceptable but because of timing (BLA action date of 16 Jan. 09), details still needed to be agreed upon, if this could become a post approval commitment we make with a completion time
This was acceptable to FDA. FDA also requested CSLB to submit a concept sheet for the pharmacovigilance plan.
The actual plan will be a PMC. CSLB was requested to submit a letter to the effect that they will carry out the PMRs where it is required by FDA.
The surrogate endpoints will be validated in a Phase IV safety and efficacy study.