What should I tell the broker before contract manufacturing begins?
For contract manufacturing, list each product and lot, manufacturer, storage site, testing role, shipment route, and whether the destination is an IND-regulated study or commercial sale. Ask how those activities appear in the proposed application and forms.
Ask the specialist which terms address product allegations, withdrawal costs, clinical-study responsibilities, and shipment conditions, including any temperature, delay, or interruption exclusions.1,6
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Sources and Further Reading for Therapeutics
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