The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance for Industry: Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
Origin/Publisher:
FDA
Content:
This guideline concerns the testing and evaluation of the viral safety of biotechnology products,and it outlines what data should be submitted in marketing application and registration packages for those products
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