S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
December 16, 2009
December 1, 2018
c9774033-823e-4e54-8323-928303b9f87d
Related Documents
S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
Guidance DocumentJune 7, 2012Center for Drug Evaluation and Research
S6(R1) Addendum: Preclinical Safety Evaluation of Biotechnology: Guidance for Industry
Guidance DocumentDecember 17, 2009Center for Drug Evaluation and Research
Q11 Development and Manufacture of Drug Substances
Guidance DocumentNovember 20, 2012Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox