Nanotech task force releases report

The FDA's Nanotechnology Task Force has released a report advising the agency to develop guidances for manufacturers and researchers to use in products that utilize such materials. The report states that nano-sized particles-1/100,000th the width of a human hair-present challenges similar to those posed by other emerging technologies used in FDA-regulated products, and a need exists for predictable regulatory pathways as applications are developed. In addition to calling for the agency to develop in-house expertise, the report suggests that the FDA create guidances that clarify what information drugmakers need to submit to the agency and when the use of nanoscale materials may change the regulatory status of particular products. According to FDA's Randall Lutter, Ph.D., deputy commissioner for policy, the new guidances will be issued according to their category (e.g., drugs, food) and should be developed within months. The task force report can be accessed on-line at http://www.fda.gov/nanotechnology/taskforce/report2007.pdf.