FDA Details “Quality Agreements” For Marketers, Contract Manufacturers
This article was originally published in The Tan Sheet
Executive Summary
The “Contract Manufacturing Arrangements for Drugs: Quality Agreements” draft guidance describes how parties involved in contract manufacturing of drugs can employ quality agreements to delineate their responsibilities and ensure drug quality,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.
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FDA Details “Quality Agreements” For Marketers, Contract Manufacturers
The “Contract Manufacturing Arrangements for Drugs: Quality Agreements” draft guidance describes how parties involved in contract manufacturing of drugs can employ quality agreements to delineate their responsibilities and ensure drug quality,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.