12/04/2008 Telecon - RiaSTAP

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application    Submission ID: 125317/0    Office: OBRR

Product:
Human Fibrinogen Concentrate, Pasteurized

Applicant:
CSL Behring GmbH

Telecon Date/Time: 04-DEC-2008 12:00 AM Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):
Other

Author: VASANTHA KUMAR

Telecon Summary:
Discussions on post marketing study BI3023_3001 and BPAC administrative clarifications

FDA Participants: Nisha Jain, Basil Golding and Jennifer Scharpf

Non-FDA Participants: CSLB

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:
Discussions on post marketing study BI3023_3001 and BPAC administrative clarifications