Department of Health and Human Services July 30, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products,'' dated July 2008. The draft guidance document provides to manufacturers of plasma-derived products recommendations for performing parvovirus B19 NAT as an in- process test for Source Plasma and recovered plasma to identify and help to prevent the use of plasma units containing high levels of parvovirus B19. The draft guidance also recommends how to report to the FDA implementation of parvovirus B19 NAT.