FDA Seeks Comment on ICH Biologics Draft

The FDA is publishing an International Conference on Harmonisation (ICH) draft guideline that updates and explains specific preclinical steps drugmakers should take to facilitate the conduct of product development and clinical trials for biotechnology-derived drugs. The guideline recommends new steps in species selection, study design and testing for immune response, toxicity and carcinogenic potential due to experience gained since a previous ICH guideline on the preclinical safety of such products was issued. Comments are due Feb. 1.
Washington Drug Letter