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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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11/07/2008 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: 07-NOV-2008 12:00 AM Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):
Other

Author: VASANTHA KUMAR

Telecon Summary:

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

Telecon Body:

CSLB wanted to clarify the following:

  1. these post-market actions are acceptable and
  2. 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.