What’s The Plan? US FDA Drug Development Tool Qualification Process Requires “Cultural Change”

The success of the new US FDA “qualification” pathway for biomarkers and other drug development tools will hinge on how outside groups – and internal agency reviewers – adapt to a new requirement to agree on a formal plan to develop the new tool.

Under the 2016 21st Century Cures Act, there is now a three-step process for outside groups to use to obtain FDA “approval” of a novel biomarker or clinical outcomes assessment for use in drug development: an initial letter of intent (LoI), then a formal “qualification plan” (QP) outlining the necessary information to support the new tool for its intended use in drug development, and then a formal submission (the FQP or final qualification package)