- They ADDRESS ISSUES RELATED TO DRUG IDENTITY, MANUFACTURING CONTROL & ANALYSIS - The DRUG SPONSOR SHOULD STATE whether it believes the chemistry of either the drug substances or the drug product presents any signals of potential human risk - The reviewing chemist evaluated the manufacturing and processing procedures - If so, these signals should be discussed, with steps proposed to monitor for such risks. Sponsors should describe any chemistry and manufacturing differences between the drug product proposed for clinical use and the drug product use in the animal toxicology trials