FDA has posted the slides and transcript of the FDA Public Meeting on the Final Assessment of the Program for Enhanced Review Transparency and Communication in PDUFA V, held March 27, 2017, in Silver Spring, Md., as well as other documents related to evaluation of the PDUFA V Program.
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 +