PPTA advocates for rational regulatory policy through active dialogue with regulatory authorities throughout the world. PPTA supports regulatory policies that help ensure the safety and quality of plasma protein therapies. Regulatory staff respond to policy documents and issues, as needed, and are actively engaged on issues ranging from the collection of source plasma through the manufacture of therapies that are administered to patients. As regulations may differ in various parts of the world, PPTA also works to promote harmonization among them, where beneficial.
Regulatory and quality policies affect every step of the plasma protein therapy lifecycle, which includes:
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 +