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

Registration is now open for the Business Forum! +

Join us on October 17 in San Diego for the 2019 Business Forum! [PPTA Members only]

Click here to register for the 2019 Business Forum. Online registration will close October 10.
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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.
Read More
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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FDA Posts Public Meeting Documents

Registration is now open for the Business Forum! +

Public Workshop Focuses on Immune Globulin Products +

FDA Posts Public Meeting Documents +

115th meeting of the FDA Blood Products Advisory Committee +

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