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Home » Trade Group Asks for Changes to FDA Guidance on ICH Q12 in Public Comment
Trade Group Asks for Changes to FDA Guidance on ICH Q12 in Public Comment
The International Society for Pharmaceutical Engineering (ISPE) has proposed changes to the FDA’s draft guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH) for makers of drugs and drug-device combination products.