S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
- S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (PDF - 137 KB) posted 11/01/97
- S6 Addendum to Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (PDF 182 KB) posted 5/17/2012
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).
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.