The Food and Drug Administration (FDA) has announced the availability of the draft guidance for industry, “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.” View the announcement published in the January 8, 2016, Federal Register, and the draft guidance below.
1/8/16 FDA Announcement
FDA Draft Guidance, “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.”