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Nov 8, 2023
Summary of the PPTA/FDA Liaison Meeting (November 8, 2023)
PDMPs — which are derived from human plasma from healthy donors — are essential for around 300,000 European patients who rely on these therapies to treat a variety of rare, chronic, and potentially life-threatening conditions, which are often genetic in origin. Without these treatments, many patients might not survive or would have a substantially diminished quality of life. In addition, plasma-derived medicines are also used in everyday treatment, such as supportive treatment in trauma cases, liver disease, cardiac surgery, and in some cases, pregnancy complications.
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PPTA statements
https://assets-global.website-files.com/638f893112c6eac0e46ac576/657b49c161b36be580c14e84_2023%20FDA%20Liaison%20Meeting%20Summary_Website_FINAL.pdf
Nov 8, 2023
Summary of the PPTA/FDA Liaison Meeting (November 8, 2023)
PDMPs — which are derived from human plasma from healthy donors — are essential for around 300,000 European patients who rely on these therapies to treat a variety of rare, chronic, and potentially life-threatening conditions, which are often genetic in origin. Without these treatments, many patients might not survive or would have a substantially diminished quality of life. In addition, plasma-derived medicines are also used in everyday treatment, such as supportive treatment in trauma cases, liver disease, cardiac surgery, and in some cases, pregnancy complications.
All
PPTA statements
https://assets-global.website-files.com/638f893112c6eac0e46ac576/657b49c161b36be580c14e84_2023%20FDA%20Liaison%20Meeting%20Summary_Website_FINAL.pdf
Oct 27, 2023
PPTA Statement on the Council’s negotiating mandate on the SoHO Regulation
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PPTA statements
Oct 27, 2023
PPTA Statement on the Council’s negotiating mandate on the SoHO Regulation
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PPTA statements
Sep 12, 2023
European Parliament Misses Opportunity to Increase Plasma Collection in Europe to Make Essential Medicines
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PPTA statements
Sep 12, 2023
European Parliament Misses Opportunity to Increase Plasma Collection in Europe to Make Essential Medicines
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PPTA statements
Aug 25, 2023
Study Confirms that Frequency of Source Plasma Donation as Regulated by U.S. FDA Does Not Impair Donor Health and Well-Being
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Press releases
Aug 25, 2023
Study Confirms that Frequency of Source Plasma Donation as Regulated by U.S. FDA Does Not Impair Donor Health and Well-Being
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Press releases
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