FDA 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
Titel:
FDA 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
Internet:
Herkunft/Verlag:
FDA Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@fda.hhs.gov, http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM516650.pdf
Dokumentenart:
Guidance
Inhalt:
Enthält FDA Empfehlungen für die Nutzung von NAT Methoden bei der Spenderprüfung für Zellen und Gewebe bzw, Zubereitungen aus diesen.