New FDA Guidance for Drug Development Tools

The U.S. Food and Drug Administration (FDA) has published a new Guidance for Industry and FDA Staff: "Qualification Process for Drug Development Tools".

This guidance describes the process for qualifying drug development tools (DDT). Like for example biomarkers, clinical outcome assessments (COAs), and animal models for drug development. The aims of the new guidance are:

  • providing a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the submitter
  • explaining the kinds of data that should be submitted to support qualification of a DDT
  • creating a mechanism for CDER's formal review of the data
  • enabling progress in drug development by applying scientific advances with new tools as part of FDA's Critical Path Initiative (CPI)

"The DDT qualification process described in this guidance is intended to expedite development of publicly available DDTs that can be widely employed. Drug developers can use a DDT that has been qualified within a specific context of use (COU) for the qualified purpose during drug development." As a result, CDER reviewers can accept DDT applications without further re-confirmation, when the DDT has been qualified.

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