FDA Guidance for Industry: Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
Title:
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