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Pharmaceutical Industry and FDA Preparing for ICH M7 Implementation

This article was originally published in The Gold Sheet

Executive Summary

The pharmaceutical industry is concerned about the cost involved in setting up complex computational systems required for evaluating potential genotoxic impurities in drug substances and drug products under ICH M7. The guidance goes into effect in January 2016 for drugs in clinical development and in July 2017 for new and generic drug applications as well as drugs with post-approval changes.

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