FDA Announcement 

The Food and Drug Administration (FDA) has announced the availability of the draft guidance for industry, “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and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 View the announcement published in the January 8, 2016, Federal Register, and the draft guidance below.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FDA Draft Guidance, “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based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