ARTICLE | Product Development

Nanotech in the clinic

August 22, 2005 7:00 AM UTC

There has been an enormous amount of hype around nanotechnology since the concept first gained currency in the biomedical field about a decade ago. Now that nanotech-derived therapeutics are entering or nearing the clinic - including a Phase II cancer treatment in Europe - an important question is whether they need special attention from regulators.

At this point, FDA argues that it is well prepared on the clinical side, in large part because most therapeutic molecules already fall into the space claimed by nanotech - which encompasses 1-100 nanometers. Thus, until nanobots crawl through veins scrubbing out plaque, the agency says the technology doesn't require any special therapeutic expertise from regulators...