Final FDA Quality Agreements Guidance Retains Focus On Commercial Manufacturing
Final US FDA guidance on contract manufacturing quality agreements retains draft version’s focus on commercial activities even though industry asked for it to also cover arrangements between manufacturers and contract partners developing investigational drugs.
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The “Contract Manufacturing Arrangements for Drugs: Quality Agreements” draft guidance describes how parties involved in contract manufacturing of drugs can employ quality agreements to delineate their responsibilities and ensure drug quality, safety and efficacy.