Qualification of Drug Development Tools: FDA Updates Process

Regulatory NewsRegulatory News | 08 June 2017 |  By 

Thanks to the 21st Century Cures Act, there will be an updated, multi-stage process for qualifying Drug Development Tools (DDTs), which include biomarkers, animal models and clinical outcome assessments.

The US Food and Drug Administration (FDA) on Thursday said its goal is to transition from the legacy process to the new one, outlined in section 507 of the law, through a phased approach and the agency is currently developing a transition plan for existing projects and templates for submission documents.

The updated process includes three submission milestones: the Letter of Intent, the Qualification Plan and the Full Qualification Package, parts of which will be posted publicly on FDA's website as part of transparency provisions in the law.

In addition to outlining the documents that will be posted (see link at bottom), FDA tells companies to contact their respective DDT qualification program with any questions.


The DDT qualification program allows FDA’s Center for Drug Evaluation and Research (CDER) to work with companies to help develop and refine a DDT for a specific use. Qualification of a DDT can allow a sponsor to use it during drug development without requesting CDER reconsider and reconfirm its suitability.

"Once qualified, DDTs will be publicly available to be used in any drug development program for the qualified context of use," FDA notes.

A list of qualified DDTs can be accessed through the following links:

Updated Process for Qualification of Drug Development Tools Under New FD&C Act Section 507

FDA Guidance on Drug Development Tools


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