Lynn L. Bergeson and Michael F. Cole, “Food and Drug Administration’s Regulation of Nanotechnology,” Daily Environment Report, Sep. 22, 2008.
The Food and Drug Administration is considering further implementation of the recommendations made by its Nanotechnology Task Force in July 2007. The authors of this article note that nanotechnology will be a fact of life for FDA-regulated products for years to come. They say nanotechnology is an important issue, but only one among many that FDA must address, and FDA’s limited resources must be allocated sensibly. The authors suggest FDA build on existing databases and correlate the information from submissions required for certain products. When the facts clearly warrant it, the authors recommend FDA issue guidance documents that set forth the issues to address in making filing determinations, but the need for such filings should follow the established, existing framework unless and until that framework is proven inadequate.