FDA Guidance for Industry “Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with H
Titel:
FDA Guidance for Industry
“Lookback” for
Hepatitis C Virus (HCV):
Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients
Based on Donor Test Results
Indicating Infection with H
Internet:
Herkunft/Verlag:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM238488.pdf
Dokumentenart:
Leitfaden für die Industrie
Inhalt:
Empfehlungen für die Erfüllung von 21CFR 610.47 und 21 CFR 610.48 für Einrichtungen der Blutspende oder Soende von Blutbestandteile,inkl. Pasma, Leukozyten, Hospitäler und sonstige Auftragnehmer.