October 03, 2019 Feature

Nano Drug Delivery: Scientific, Patent Law, and FDA Regulatory Perspectives

By Raj Bawa, MS, PhD

Nano Frontiers: A Brief Introduction

The air is thick with news of nano-breakthroughs. Although “nano” (nanotech or nanotechnology) is a hot topic for discussion in industry, pharma, patent offices, and regulatory agencies, the average citizen knows very little about what constitutes a nanoproduct, a nanomaterial, or a nanodrug. Still, there is no shortage of excitement and confusion when it comes to anything nano. Optimists tout nano as an enabling technology, a sort of next industrial revolution that could enhance the wealth and health of nations. They promise, in particular, that areas within nanomedicine (nanoscale drug delivery systems, theranostics, nanoimaging, etc.) will soon be a healthcare game-changer by offering patients access to personalized or precision medicine. Pessimists, on the other hand, take a cautionary position, preaching instead a go-slow approach, pointing to a lack of scientific information on health risks, general failure on the part of regulatory agencies to formulate clearer guidelines and issuance of patents of dubious scope by patent offices. They highlight that nano is burdened with inflated expectations and hype. As usual, the reality is somewhere between such extremes. Like any emerging technology, the whole picture has yet to emerge, and we are just getting started! Whatever your stance, nano has already permeated virtually every sector of the global economy, with potential applications consistently inching their way into the marketplace. But is nano the driving force behind a new industrial revolution in the making or simply a repacking of old scientific ideas and terms? Dissecting hope from hype is not straightforward.

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