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GUIDANCE DOCUMENT

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

Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0573
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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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0573.

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