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Jan 09, 2014

FDA Releases Final Guidance on Qualification Process for Drug Development Tools

Published

Jan 09, 2014

On Jan. 6, FDA released final guidance outlining the qualification process for drug development tools (DDTs).

The purpose of this guidance is to provide a framework for interactions between the Center for Drug Evaluation and Research (CDER) and sponsors proposing a DDT for qualification.  According to FDA, DDTs are methods, materials or measures that assist in drug development and include (but are not limited to) biomarkers, clinical outcome assessments and animal models used for drug development.  This guidance includes specific descriptions of each type of DDT for which qualification programs have been established.  In addition, FDA dictates the type of data to submit to support qualification of a DDT, thus creating a mechanism for CDER’s formal review.

The DDT qualification process outlined in this guidance is intended to expedite development of publicly available DDTs that could be widely utilized by drug developers.  Once qualified, DDTs may be used during drug development for the qualified purpose as long as the following criteria are met: According to the final guidance, the DDT qualification process should enable CDER to advise DDT developers and provide concurrence for the DDT use that is not limited to a single, specific drug development program.  As a result, CDER believes that making DDTs widely known and available for use by drug developers will contribute to drug innovation.  In the future, CDER intends to make public the DDT qualification and the COU statement when those determinations are made in accordance with the process described in the final guidance.

  • The study is conducted properly with all procedures and protocols in context of use (COU).
  • The DDT is used for the qualified purpose.
  • New information conflicting with the basis for the qualification does not exist.

To view the Final FDA guidance, click here.

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