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

Save the Date for IPAW 2020! +

Mark your calendars! International Plasma Awareness Week (IPAW) will be held October 5-9.

This event is held annually and is designed to:
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Regulatory Policy Bulletin Board

Final Summary FDA Liaison Meeting: November 6, 2019 +

The following is a summary of the PPTA-FDA Liaison Meeting held on November 6, 2019, in Rockville, Maryland. The RPSC met on November 5^th to prep for the Liaison meeting and finalize presentations.
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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

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FDA Posts Public Meeting Documents

Save the Date for IPAW 2020! +

Final Summary FDA Liaison Meeting: November 6, 2019 +

Public Workshop Focuses on Immune Globulin Products +

FDA Posts Public Meeting Documents +

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