S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals

2 November 2022 – FDA published S1B(R1) as an addendum to the current ICH S1 guidance for industry.

This Addendum applies to all pharmaceuticals that need carcinogenicity testing as described in ICH S1A. This Addendum expands the evaluation process for assessing human carcinogenic risk of pharmaceuticals by introducing an additional approach that is not described in the original ICH S1B.

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