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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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12/23/2008 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: 23-DEC-2008 12:00 AM Initiated by FDA? Yes
Telephone Number:

Communication Categorie(s):
Other

Author: VASANTHA KUMAR

Telecon Summary:
1) CSLB requested BLA review update and written response.
2) Request for additional information to support categorical exclusion.

FDA Participants: Rebecca Olin, Laura Wood and Vasantha Kumar

Non-FDA Participants:

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:
1) CSLB requested BLA review update and written response.
2) Request for additional information to support categorical exclusion.