US FDA seeks input on nanotechnology guidelines
This article was originally published in Scrip
Executive Summary
The US FDAwill gather public comments and data at a September 8th meeting to aid the development of guidelines for nanotechnology products. Last year an agency task force report recommended development of various guidance documents on the use of nanoscale materials (Scrip Online, July 26th, 2007). These included guidelines for sponsors on identifying the particle size for drugs and biologicals, and for submitting information on how nanoscale materials affect the manufacturing process. The meeting's primary purpose is to determine what factors the FDA should consider in providing guidance on the information and data needed to demonstrate safety and effectiveness of products containing nanoscale materials, and the circumstances under which a product's regulatory status might change owing to the presence or use of nanoscale materials.