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FDA Encourages 'Established Conditions' Use Despite ICH Q12 Uncertainty

Executive Summary

Go ahead and list the 'established conditions' in your NDAs, ANDAs and BLAs that require regulatory notification in the event of post-approval changes, which leaves all other CMC changes to be managed internally, FDA tells industry. But the agency wants a heads up if you're planning to do that, as the 'established conditions' paradigm continues to evolve in the context of ICH Q12 deliberations.


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