FDA Posts Public Meeting Documents

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
Bulletin Board

Highlights from the 2018 IPPC +

Mr. Jan M. Bult, President & CEO, PPTA, opened the well-attended IPPC 2018 by welcoming the more than 300 attendees to Budapest. PPTA thanks its sponsors who help make the IPPC possible every year. Download the IPPC app (available in the Apple AppStore and Android Market/Google Play) for Apple or Android devices) for a complete list of sessions and many of the presentations.
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2017 Plasma Protein Forum Highlights +

Following welcoming remarks from Jan M. Bult, PPTA President & CEO, the 2017 Plasma Protein Forum kicked off with a message from Mr. David Bell, Chairman of the PPTA Global Board of Directors. Mr. Bell noted the importance of educating patients, legislators, regulators, and the public on how safety & efficacy standards, donor compensation, and adequate reimbursement is necessary to ensure access to care for all who need it.
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Regulatory Policy
Bulletin Board

Public Workshop Focuses on Immune Globulin Products +

On Nov. 8-9, the U.S. Food and Drug Administration (FDA) is conducting a public workshop entitled "Immune Globulin Potency in the 21st Century." The purpose of the public workshop is to discuss new challenges to meet U.S. potency requirements for Immune Globulin (IG) products and to identify measures to address these challenges.
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FDA Posts Public Meeting Documents +

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.
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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.
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