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



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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