In that case, the FDA also had to rush out an unapproved test to detect the West Nile virus in the blood supply, Ziman said. Such tests are now approved.
“We are gathering data on the performance of the test while the test is in a sense being required by the FDA,” she said.
Because the products are investigational, UCLA will need special permission from an independent ethics committee known as an Institutional Review Board, then each patient will need to sign a special consent form before receiving a transfusion.
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