A critical path approach to advance nanoengineered medical products

Still needed in nanotechnology is a product development toolkit containing both scientific and business strategies to stimulate innovation. Among the scientific tools envisioned are evaluative and predictive test methods, such as animal- and computer-based predictive models, characterization assays, toxicity tests and quantitative imaging methods to track biodistribution of nanoparticles in complex biological systems. These tools will help bridge scientific gaps and elucidate potential benefits and risks related to use of nanoengineered medical products. In addition, relevant business strategies, if carefully designed, will help overcome many of the hurdles in this field. This article describes some needed scientific/regulatory and business tools of this field and introduces one collaborative effort underway – a Critical Path Initiative [FDA's Critical Path Initiative: http://www.fda.gov/oc/initiatives/criticalpath/.] – structured to bridge some existing gaps.

Section editor:Janet Woodcock – Food and Drug Administration, Rockville, MD, USA