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.
Meetings and Events
Register now for the 2017 Plasma Protein Forum! +
The 2017 Plasma Protein Forum will be held Tuesday, June 13 - Wednesday, June 14 at the Washington Marriott Georgetown in Washington, D.C.
Registration for the Forum includes access to all general sessions, the exhibit hall and all Forum breaks (you must be registered in order to participate in any of the Forum activities).Read More
Highlights from IPPC 2017 +
Mr. Bruno Santoni, Executive Director, PPTA Europe, opened the well-attended IPPC 2017 welcoming the more than 300 attendees to Prague. PPTA thanks its sponsors who help make the IPPC possible. Download the IPPC app for a complete list of sessions and many of the presentations.Read More
2016 Plasma Protein Forum Highlights +
Dr. Shari Ling, Deputy Chief Medical Officer, Centers for Medicare and Medicaid Services (CMS), delivered the Keynote opening up the 2016 PPF. Dr. Ling's remarks highlighted CMS's movement towards value based purchasing and quality based payment programs.Read More
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 +