01/12/2009 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: 12-JAN-2009 12:00 AM Initiated by FDA? Yes
Telephone Number:

Communication Categorie(s):
Other

Author: VASANTHA KUMAR

Telecon Summary:
Requests for postmarketing commitment studies for perioperative and prophylaxis and labeling clarifications.

FDA Participants: Nisha Jain

Non-FDA Participants: CSLB

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:
Requests for postmarketing commitment studies for perioperative and prophylaxis and labeling clarifications.