Ressources

The CBER Surveillance Program BEST Initiative recently posted its Assessment of Immune Globulin Utilization in Commercially insured and Medicare Populations study report. The aim of the study is to provide a better picture of the evolution of Ig use over a 10-year longitudinal period in the context of emerging scientific evidence and clinical trends. PPTA developed an Executive Summary of the study report, highlighting key observations, findings, and conclusions.

"PPTA's voluntary standards program provides global leadership for the plasma protein industry's goal of continuous improvement with a focus on safety and quality from the donor to the patient. The standards program will be transparent, credible, innovative and responsive to stakeholder and industry needs." - Mission Statement, PPTA Voluntary Standards Program

PPTA welcomes the revision of the EU pharmaceutical legislation as an opportunity to improve access to therapies, including life-saving plasma-derived medicinal products (PDMPs) for EU patients. A revised framework has the potential to provide a robust set of provisions that will continue to ensure the safety and quality of human plasma used for manufacturing, while upholding the safety, quality, and efficacy of PDMPs.

Facts about Qualified Donor Standard.