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Blood Products Advisory Committee

On Tuesday to Wednesday, April 4-5, 2017, the Blood Products Advisory Committee (BPAC) met to discuss Novo Nordisk’s Biologics License Application (BLA 125611), for Recombinant Human Coagulation Factor IX, GlycoPEGylated. The product is also referred to as nonacog beta pegol or N9-GP.

In a separate Tuesday afternoon session, the Committee heard a summary of responses to Docket FDA-2016-N-1502: Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.

On Wednesday, April 5, 2017, the Committee heard presentations on the research programs in the Laboratory of Emerging Pathogens in the Division of Emerging Transfusion-Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.