- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
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).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2009-D-0573.