Regulating Nanomedicine

The emergence of nanotechnology as a viable drug delivery system has opened many new venues into medicinal applications over the past decade. However, Nanomedicine's great promises are, at times, overshadowed by its potential downfalls. This article discusses the importance of regulating nanomedicine from the point of view of the FDA's Nanotechnology Task Force.

In the wake of drug recalls with unforseen side effects and in the atmosphere of pre-emptive measures, the FDA Nanotechnology Task Force was created to set specific guidelines to regulate nanomedicine. Concern about assessing toxicity and environmental exposure to nanomaterials such as self-assembled complexes, dendrimers or inorganic nanotubes need to be addressed. Engineered nanoparticles are highly reactive and mobile within the human body, and there are
currently no effective methods of monitoring ENP exposure risks in patients or health care workers.

Currently, there are over 215+ medical companies developing or researching nanomedicine within the United States; nanomedicine earned a $2.6 billion gross product market in 2004. Such a large market requires regulation to control the limits, set guidelines, and ensure public and enviromental safety.

http://www.nature.com/nmat/journal/v6/n4/full/nmat1875.html