Bring nanomedicines to market: regulatory challenges, opportunities, and uncertainties

The authors of this article review the major physiochemical, biologic, and functional characteristics of several nanomedicine products currently in use to explore what makes these products unique and a commercial success. The main benefits of the products reviewed are that they provide drugs with site-specific therapeutic action and its ability to reduce potential side-effects. The authors then go on to look at some of the regulatory compliance challenges faced by nanodrugs, and looks at the major stages that the drugs will have to go through for approval by the U.S. Food and Drug Administration. The article reviews these challenges in detail, and finishes with giving synopses of two major drugs that have already gone through the approval process, Rapamune and Abraxane, and looks at why these drugs made it through successfully.