The U.S. Food and Drug Administration said that the Nanotechnology Task Force has produced a report in which it recommends the US agency to develop guidance and other tasks pertaining to the establishment of benefits and risks associated with drugs developed using nanotechnology, a scientific field that is gaining much scientific development in recent years.
Nanotechnology is a new area of scientific knowledge that deals with the use of materials and devices at the “nano” scale. One nanometer (abbreviated as nm) is one billionth, (or 1/1,000,000,000) of a meter. This is truly at the level of molecules. See here for a comparative view of the sizes of commonly known items and nanoscale particles.
Nanotechnology and working materials at the nano scale exhibit rather different properties that same materials at other scales. Properties exhibited by materials at the nanometer scale are very unique. For example, copper, an opaque material may become transparent at the nano scale. Gold and platinum which are inert compounds may become reactive at the nanometer scale.
Nanotechnology is sometime referred as molecular manufacturing since nanosystems could be viewed as machines at the nanometer level. It is the view of the Nanotechnology’s Task Force that “nanoscale materials potentially could be used in most product types regulated by FDA” so it is necessary to address and study possible risks associated with such new technology.
Regulations should also be in place to assure not to misuse this are of scientific knowledge and avoid potential risks.
One area of nanotechnology application is medicine. Medical and engineering researchers work at the micro- and nano-scales to develop new drug delivery methods, therapeutics and pharmaceuticals. The FDA is already seeing a rapid interest in getting products approved that have been manufactured using nanotechnology. That is why this special Task Force is asking FDA to take steps to ensure transparent, consistent, and predictable regulatory pathways.
Twenty-three agencies (including the FDA) have formed the National Nanotechnology Initiative (NNI). The NNI is a federal program established to coordinate research and development efforts in regard to all aspects of the nanotechnology field including the science, engineering, technology, and potential uses. According to their web site, the NNI will ensure that the US remains leader in nanotechnology for a better human health and improved
Economic Wealth and National Security.
The report also asks for the FDA to create, maintain, and manage a data to better regulate nanotechnology products especially with respect to biological effects. The reports states that in-house expertise should be developed by the US government agency.
FDA Nanotechnology Report Outlines Scientific, Regulatory Challenges. Press Release. URL: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01671.html
Nanotechnology. A Report of the U.S. Food and Drug Administration Nanotechnology Task Force
July 25, 2007. URL: http://www.fda.gov/nanotechnology/taskforce/report2007.html
National Nanotechnology Initiative (NNI) Web site. URL: http://www.nano.gov/