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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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10/20/2008 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: 20-OCT-2008 12:00 AM Initiated by FDA? Yes
Telephone Number:

 Communication Categorie(s):
Advice

  Author: VASANTHA KUMAR

Telecon Summary:
Advice

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

 Telecon :
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.