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Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
Short Title:Q5A
Internet:http://www.fda.gov/cder/guidance/Q5A-fnl.pdf
Origin/Publisher: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/cder/guidance/index.htm
Content:This guideline is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin.
Document Type:FDA Guidance for Industry