FDA Releases Guidance: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus

FDA Draft Guidance: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products

Federal Register Announcement, August 17, 2016

FDA Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and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, published January 2016

FDA Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), published August 8, 2007

NILA News

5/24/2024
FDA Publishes Proposed Enforcement Policies for Tests During a Declared Emergency

5/6/2024
Final Rule on LDTs officially published in Federal Register

4/29/2024
NILA and American Association of Bioanalysts (AAB) Respond to FDA's Release of Final Rule on LDTs

Laboratory Outreach Communications System (LOCS)

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