A (not) new Rx: Quality Improvement for NAM.

New Approach Methodologies (NAMs) are a rapidly growing set of tools/methods for use food, drug, consumer product, or chemical safety assessment paradigms. The massive growth in NAMs tech development, publication, and legislation has been paralleled by a growing sense of frustration. The challenge of realizing the systems-level changes needed to catalyze the broad-scale adoption and use of NAMs is substantial. This Commentary asserts that these challenges may be less unique than perceived to date, and points to specific opportunities to learn from decades of experience (both positive and negative) from the Quality Improvement (QI) movement in the public health and healthcare arenas. Specific recommendations to inform and guide NAMs development are offered. • The NAM arena can learn from decades of experience in the public health and healthcare Quality Improvement movements. • Before selecting or implementing any NAM approach, users should first clearly define the desired system improvement. • Systems change requires iterative engagements within a complex, multi-stakeholder and multi-setting ecosystem. [ABSTRACT FROM AUTHOR]