The addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals has been published and is open for comments. The document can be downloaded from:
EMEA - http://www.emea.europa.eu/pdfs/human/ich/030295enfin.pdf
FDA - http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194490.pdf
ICH - http://www.ich.org/LOB/media/MEDIA503.pdf
Deadline for comments is February 2010
Tuesday, January 5, 2010
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