FDA's evolving approach to nanotechnology

Nanotechnology has emerged as an industry with the potential to change many products regulated by the FDA. While the FDA has been regulating products containing nanoscale materials for several years, questions concerning the effectiveness of existing regulations have emerged. After a period of study and analysis, the FDA has issued three (3) draft guidance documents over the last eighteen (18) months pertaining to the use of nanoscale materials and nanotechnology in certain FDA-regulated products. As these are likely to become the "de facto" standards they merit further analysis. This article examines these draft guidance documents and provides modest commentary for those practicing in the area.