Tag: Drug Development Tools

FDA Guidance for Industry and FDA Staff: Qualification Process for Drug Development Tools [DRAFT]

This draft guidance provides FDA’s current thinking regarding the qualification process for drug development tools (DDTs) for a specific use, as defined in the 21st Century Cures Act. Qualification is a voluntary process that permits use of a DDT for its context of use— the defined boundaries within which the available data justifies use of […]

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