Federal Register Notice: FDA is making available a guidance prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) entitled Q9 Quality Risk Management. The guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. To download this guidance, click here. To view this notice, click here.