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  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Donor Screening to Reduce Hepatitis B Transmission

    The US Food and Drug Administration (FDA) on Wednesday finalized its guidance on reducing the risk of hepatitis B virus (HBV) transmission via human cells, tissues and cellular and tissue-based products (HCT/Ps) by screening donors with nucleic acid tests (NAT). Specifically, FDA says that HCT/P establishments should add nucleic acid tests for HBV to their testing arsenal as the new tests offer significant improvements in how early the virus can be detected. "FDA-licens...
  • Final Guidance for Blood Product Testing Released by FDA

    The US Food and Drug Administration (FDA) has released a final guidance regarding the use of nucleic acid tests (NATs) to reduce the transmission of hepatitis B, part of a strategy the agency says it hopes will assist in the screening of blood and plasma donors for the virus. The final guidance comes nearly a year after the agency first released the draft version of the guidance . FDA said it considers Hepatitis B (HBV) NATs to be "necessary to reduce adequately and a...