Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

10 November 2022 – FDA published draft guidance on Q5A(R2) viral safety evaluation of biotechnology products. Submit comments by 14 January 2023.

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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