International Conference on Harmonisation; Addendum to International Conference on Harmonisation Guidance on S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S6 Addendum to Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals" (S6 addendum). The S6 addendum was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The S6 addendum is intended to incorporate new knowledge and experience gained since the implementation of the ICH guidance entitled "S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals" (ICH S6) and to clarify and provide greater detail to enable the development of safe and effective biopharmaceuticals.