Last week the FDA posted a press release on the news section of FDA.gov announcing a "collaboration initiative" with the Alliance for Nanohealth (www.nanohealth.org) . The press release may be accessed at http://www.fda.gov/bbs/topics/NEWS/2009/NEW01971.html. FDA and ANH will work together "to expand knowledge of how nanoparticles behave and affect biologic systems and to facilitate the development of tests and processes" to lower possible risks that might be associated with nanoengineered products.
The "Memorandum of Understanding" (MOU) between FDA and ANH, published in the Federal Register 03/13/2009 (72 FR 10927), makes it clear that this collaboration has two major goals:
1) "Moving nanoengineered medical products from the preclinical stages of development through clinical stages and then to commercialization."
2) "Understanding the risks and benefits of nano-engineered medical product development to the extent that this information can faciliatate the regulatory review and evaluation of new medical products that incorporate nanotechnology."
The MOU can be found at http://www.access.gpo.gov/su_docs/fedreg/a090313c.html