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Food and Drug Administration

Blood Products Advisory Committee

January 9, 2009

BRIEFING INFORMATION

 Topic 1

Sponsor

CSL Behring Briefing Document – Human Fibrinogen Concentrate (RIASTAPTM) (pdf)

CSL Behring Briefing Document Errata (htm)

FDA

Original FDA Briefing Document, Topic 1: RIASTAPTM [Fibrinogen concentrate (Human)], CSL Behring (pdf)

Errata for original version of FDA briefing Document, Topic 1: RIASTAPTM (htm)

                        Revised FDA Briefing Document, Topic 1: RIASTAPTM [Fibrinogen concentrate (Human)], CSL Behring  (pdf)     

Topic 2

Sponsor

GTC Biopharmaceuticals Inc.Briefing Document – AtrynR (Antithrombin III [Recombinant]) for Injection (pdf)

FDA

Briefing Document - AtrynR [antithrombin III (Recombinant)] (htm)

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References (htm)


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