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GUIDANCE DOCUMENT

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

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

Note: In June 2011, the ICH incorporated the S6 Addendum with S6 and retitled the combined document S6(R1). The contents of S6 and the S6 Addendum reflect the contents of S6(R1).

Back to: International Conference on Harmonisation - Safety


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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:

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Food and Drug Administration
5630 Fishers Lane, Rm 1061
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All comments should be identified with the title of the guidance.