Food and Drug Administration

Blood Products Advisory Committee

January 9, 2009

SLIDES

 Topic I:  CSL Behring’s Biologics License Application for Plasma-Derived Fibrinogen
Concentrate for Treatment of Bleeding in Congenital Fibrinogen Deficiency

Introduction and Review of Clinical Data,  Nisha Jain, M.D., DH, OBRR, FDA  (htm)

Sponsor - CSL Behring Presentations (pdf)

FDA Review of Manufacturing, Timothy Lee, Ph.D., DH, OBRR, FDA (htm)

 

Committee Update - FDA Draft Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable rDNA Construct and Overview of the Center for Veterinary Medicine’s Review of the New Animal Drug Application Pertaining to the Genetically Engineered Animals Producing Milk that Contains Recombinant Antithrombin III and the Environmental Assessment for the Application, Larisa Rudenko, Ph.D., Center for Veterinary Medicine, FDA (htm)

Topic II:  GTC Biotherapeutics Inc. Biologics License Application for Recombinant Antithrombin III  Derived from Genetically Engineered Goats for Treatment of Patients with Hereditary  Antithrombin III Deficiency to Prevent Thrombosis During High Risk Situations like Surgery and Obstetrical Procedures

Introduction and Review of Clinical Data, Nisha Jain, M.D., DH, OBRR, FDA (htm)

Sponsor - GTC Biotherapeutics, Inc. Presentations (htm)

FDA Review of Manufacturing, Roman Drews, Ph.D., DH, OBRR, FDA (htm)

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