FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Issues Guidance on Dried Plasma Products for Blood Transfusions

Nov. 6, 2018
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The FDA offered recommendations for developers of dried plasma products used in blood transfusions in new draft guidance.

Sponsors using dried plasma from pooled donations should consider additional safety measures to reduce the risk of disease transmission, the agency said, such as using input plasma that has been treated with an FDA-approved pathogen reduction device.

In addition, the guidance states they should develop products that can be administered regardless of a patient’s blood type and should “consider the use of input plasma from AB donors or A donors with low anti-B titers, either as individual units or manufactured from pools of multiple units.”

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