And from the FDA’s Guidance for Industry - S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
The range and type of genotoxicity studies routinely conducted for pharmaceuticals are not applicable to biotechnology-derived pharmaceuticals and therefore are not needed....
The principles outlined in this guidance may also be applicable to recombinant DNA protein, vaccines, chemically synthesized peptides, plasma derived products, endogenous proteins extracted from human tissue, and oligonucleotide drugs.
Clearly, it’s not straightforward….
And from the FDA’s Guidance for Industry - S6 Preclinical Safety...
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