Home » FDA Seeks Comment on ICH Biologics Draft
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
Washington Drug Letter
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