The FDA has established 3 programs for qualification of Drug Development Tools (DDT):
A qualified DDT is publicly available to be used in any drug development program for its qualified context of use, and when used as qualified will not require FDA reconsideration of suitability. Since the qualification process requires an investment of resources, the program encourages the formation of collaborations to share the cost of DDT development. Following the passage of the 21st Century Cures Act, the FDA will start publishing certain details of program submissions to increase the transparency of the program. Read more about what will be publicly available here. Learn a little more by reading this previous post on the FDA’s biomarker qualification program and this previous post on the draft guidance for the evidence needed to successfully qualify a biomarker.
Reach out to me if you want to know more or discuss your medical product development challenges.
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