This is a copy of the slides presented at the meeting but not formally written up for the volume.

While certain types of nanotechnology applications have already been used in marketed products, it appears that the future holds many more opportunities for diverse applications of nanotechnology in products that will be regulated by the Food and Drug Administration (FDA). To this end, the FDA is taking steps to prepare for the arrival of these novel applications of nanotechnology. In the presentation, some of the steps taken by the FDA to meet the challenges of nanotechnology will be described. Specifically, challenges in nanotechnology applications for drug products and drug delivery systems will be considered. Scientific considerations that have taken place within the Center for Drug Evaluation and Research (CDER) will be discussed and some of the research projects initiated within CDER and focusing on better a understanding certain safety and characterization issues for nanotechnology materials will be mentioned.