FDA Guidance for Industry: Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
Titel:
FDA Guidance for Industry: Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
Internet:
Herkunft/Verlag:
Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm ; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073454.pdf
Dokumentenart:
FDA Guidance for Industry
Inhalt:
Diese Guideline behandelt die Prüfung und Bestimmung der Sicherheit biotechnologisch mit Hilfe von humanen oder tierischen Zellinien hergestellter Produkte in Bezug auf ihre virale Kontamination.