The FDA has announced a forthcoming public advisory committee meeting of the Blood Products Advisory Committee (BPAC) on Nov. 17-18, 2016, in Silver Spring, Md. On the morning of Nov. 17, the Committee will meet in open session to discuss strategies to manage iron deficiency associated with blood donation.
The Committee will also discuss proposed procedures for assuring donor safety for collections of blood from female donors with hemoglobin values of 12.0–12.4 g/dL or a hematocrit value between 36 and 38 percent. In the afternoon, the Committee will meet in open session to discuss adverse reactions related to blood donation in teenage (16 to 18 years) donors, and the effectiveness of several mitigation measures. On Nov. 18, the Committee will meet in open session to hear an informational session on Zika virus and blood safety in the United States.
FDA Posts Public Meeting Documents +
115th meeting of the FDA Blood Products Advisory Committee +
On April 4, PPTA staff attended the 115th meeting of the FDA Blood Products Advisory Committee in Silver Spring, Md. In the morning, the Biologics License Application of Novo Nordisk's Recombinant Human Coagulation Factor IX, GlycoPEGylated, was discussed. Committee comments focused on the safety of the product, including risks in the intended population, particularly in the pediatric and elderly populations, and in the setting of life-time administration, and whether monitoring—particularly of neurologic function—should be provided for the safety of patients or study subjects.Read More
PPTA Presents at ACBTSA Meeting +
PPTA Standards Programs