Federal Register Notice: FDA is making available a guidance, Q8 Pharmaceutical Development, prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The document describes suggested contents for the pharmaceutical development section of a regulatory submission in the ICH M4 Common Technical Document format. It also indicates areas where the provision of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. To download this guidance, click here. To view this notice, click here.