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

 
• By Michael McCaughan

FDA sees negotiating formal “qualification plan” as key process improvement that should ultimately accelerate pace for construction of biomarkers and other drug development tools. But it will take some getting used to.

Binoculars hang on a wooden fence background
Sponsors and the US FDA are going to need to change the way they look at biomarker development.

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...

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