S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals May 2012

GUIDANCE DOCUMENT

• Issued by: Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research

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. 

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Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.