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AABB submits comments to FDA on bacterial detection testing draft guidance

AABB SmartBrief | Mar 20, 2015

AABB has submitted comments to FDA on its draft guidance, "Bacterial Detection Testing by Blood and Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion." Based on a review of the FDA's recommendations and with input from the Transfusion Transmitted Diseases Committee and its Bacterial Contamination Work Group, AABB recommends that FDA mandate the implementation of one of two enhanced safety strategies: bacterial testing or pathogen reduction with FDA-approved or cleared technologies. In addition, the association recommends that FDA clearly delineate the pathway to licensing 7-day platelets through increased bacterial testing or pathogen reduction with FDA-approved or cleared technologies. AABB believes that simplifying the recommended testing process would facilitate its successful implementation by blood centers and transfusion services. To that end, AABB recommends confining secondary testing to a single, one-time event which would be sufficient to extend the platelet product expiration date through day seven. In addition, the comments include recommendations and requests for clarification regarding a number of specific recommendations in the guidance. Blank (03/19)


Study projects increase in chronic brain bleeding in U.S.

AABB SmartBrief | Mar 23, 2015

Scientists identify leukemia mutations linked to relapse

AABB SmartBrief | Mar 24, 2015

Study links viral mutations with false-negative tests for hepatitis B

AABB SmartBrief | Mar 23, 2015

Analysis examines anticoagulant use by atrial fibrillation patients

AABB SmartBrief | Mar 26, 2015

Anti-clot device implanted in atrial fibrillation patients

AABB SmartBrief | Mar 24, 2015

Study compares stenting with blood thinners for stroke prevention

AABB SmartBrief | Mar 25, 2015

Imaging study finds brain swelling in fatal pediatric malaria cases

AABB SmartBrief | Mar 20, 2015

Platelets produced in silk model of human bone marrow

AABB SmartBrief | Mar 23, 2015

Study looks at vitamin D deficiency, sickle cell complications

AABB SmartBrief | Mar 25, 2015


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AABB extends free shipping offer for books through March 29

AABB SmartBrief | Mar 23, 2015

AABB submits comments to FDA on bacterial detection testing draft guidance

AABB SmartBrief | Mar 20, 2015




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