What’s The Plan? US FDA Drug Development Tool Qualification Process Requires “Cultural Change”
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.
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Commissioner Gottlieb, who worked at FDA when modeling and simulation office was created and fostered growth of the techniques, expects that new drug development science office could do the same thing for biomarkers.
FDA's proposed review timeline to qualify biomarkers, clinical outcome assessments, and animal models can actually be pretty quick – assuming submissions clear the initial "reviewability" hurdle.
US agency will be more 'proactive' in engaging with outside groups interested in using the biomarker qualification process using the new resources and directives of the 21st Century Cures Act and the pending Prescription Drug User Fee Act reauthorization.