Issue Date: May 15, 2012
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Safety
Status: Final
S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology – Derived Pharmaceuticals
This addendum should be read in close conjunction with the original ICH S6 guidance (ICH S6) . In general the addendum is complementary to the guidance, and where the addendum differs from ICH S6, the guidance in the addendum prevails.
Download the Guidance Document
