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:
PPTA Presents at ACBTSA Meeting +
PPTA Attends the 114th Meeting of the FDA Blood Products Advisory Committee (BPAC) +
On Nov. 17-18, the 114th meeting of the FDA Blood Products Advisory Committee (BPAC) was held. During BPAC's discussion of strategies to manage iron deficiency associated with blood donation in the morning of Nov. 17, PPTA presented results of the Association's study of ferritin levels in Source Plasma donors.Read More
FDA Announces Meeting Date: Blood Products Advisory Committee +
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.Read More
PPTA Standards Programs