PPTA Statements

[FDA Blood Products Advisory Committee: July 20, 2009]

The Plasma Protein Therapeutics Association (PPTA) is pleased to provide comments to the Blood Products Advisory Committee (BPAC) on the issue of clinical and surrogate endpoints for evaluating efficacy of Alpha 1-Proteinase Inhibitor (A1-PI) therapies.

PPTA member companies are committed to providing safe and effective therapies and PPTA understands that patients who rely on these often life-saving therapies may have concerns about the possible transmission of Swine Influenza Virus through them in view of the recent outbreak in humans. Therapies produced by PPTA members remain safe and available.

[FDA Blood Products Advisory Committee: April 2, 2009]

The Plasma Protein Therapeutics Association (PPTA) is pleased to provide comments to the Blood Products Advisory Committee (BPAC) on the issue of plasma obtained from whole blood donors for further manufacturing use.

PPTA members are committed to providing safe and effective therapies and PPTA understands that patients who rely on plasma protein therapies may have concerns about the possible transmission of highly virulent strains of influenza H5N1 viruses through these therapies. Therefore, PPTA members continue to work to ensure that these viruses or any other emerging disease, do not compromise the safety of plasma protein therapies.

[FDA Blood Products Advisory Committee: July 21, 2005]

The Plasma Protein Therapeutics Association (PPTA) is pleased to provide comments to the Blood Products Advisory Committee (BPAC) on the issue of management of donors and units that test positive for Hepatitis B Virus (HBV) DNA by Nucleic Acid Tests (NAT).

[FDA Blood Products Advisory Committee: July 21, 2005]

The Plasma Protein Therapeutics Association (PPTA) appreciates actions taken by the FDA and the Blood Products Advisory Committee (BPAC) with respect to the safety of albumin.

[FDA Blood Products Advisory Committee: July 21, 2005]

The Plasma Protein Therapeutics Association (PPTA) appreciates actions taken by the FDA and the Department of Health and Human Services in holding a workshop to discuss very rare blood disorders.

[FDA Blood Products Advisory Committee: October 21-22, 2004]

The Plasma Protein Therapeutics Association (PPTA) is the international trade association and standards-setting organization for the world's major producers of plasma-derived and recombinant analog therapies.

[FDA Blood Products Advisory Committee: July 22, 2004]

The Plasma Protein Therapeutics Association (PPTA) is the international trade association and standards-setting organization for the world’s major producers of plasma-derived and recombinant analog therapies.