The 48th meeting of the U.S. Department of Health & Human Services (HHS) Advisory Committee for Blood & Tissue Safety & Availability (ACBTSA) was held on Nov. 28-29.
The RAND Corporation presented a research report on the HHS sponsored study, "Toward a Sustainable Blood Supply in the United States: An Analysis of the Current System and Alternatives for the Future," which covered RAND’s research, findings, outlook, and recommendations. PPTA's comments focused on re-evaluating requirements for donor screening assays in light of the few manufacturers in the U.S. market. ACBTSA also heard results of the 2015 National Blood Collection and Utilization Survey from the Centers for Disease Control & Prevention as well as an update on the Nov. 17-18 Blood Products Advisory Committee meeting from the U.S. Food & Drug Administration. ACBTSA discussed the RAND report and developed appropriate, unanimous findings and recommendations for HHS consideration. The PPTA Vice President, Global Regulatory Policy, serves on ACBTSA.
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 +