Public meeting is Oct 10 2006
August 9, 2006 — /MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM)/ — COSTA MESA CA USA — Acting FDA Commissioner Andrew C. von Eschenbach MD, today announced it has formed an internal FDA Nanotechnology Task Force. The new task force is charged with determining regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated products that use nanotech materials.
The task force will identify and recommend ways to address any knowledge or policy gaps that exist, officials note, so as to better enable FDA to evaluate possible adverse health effects from FDA-regulated products that use nanotech materials. The FDA will continue to address product-specific nanotech-related issues on an ongoing basis.
“As this exciting new area of science develops, FDA must be positioned to address both health promotion and protection challenges that it may present,” said Dr. von Eschenbach. “Through this task force, we are leveraging our expertise and resources to guide the science and technology in the development of nanotechnology-based applications.”
SPECIFICALLY, THE TASK FORCE WILL:
— Chair a public meeting Oct 10 2006, to help FDA further its understanding of developments in nanotech materials that pertain to FDA-regulated products, including new and emerging scientific issues. Those include biological interactions that may lead to either beneficial or adverse health effects.
— Assess the current state of scientific knowledge pertaining to nanotech materials for purposes of carrying out FDA’s mission.
— Evaluate the effectiveness of the agency’s regulatory approaches and authorities to meet any unique challenge that may be presented by using nanotech materials in FDA-regulated products.
— Explore opportunities to foster innovation using nanotech materials to develop safe and effective drugs, biologics and devices, and to develop safe foods, feeds and cosmetics.
— Continue to strengthen FDA’s collaborative relationships with other federal agencies, including ones participating in the National Nanotechnology Initiative, to gather information on nanotech materials used or that could be used in FDA-regulated products.
— Consider appropriate vehicles for communicating with the public about the use of nanotech materials in FDA-regulated products.
— Submit its initial findings and recommendations to the Acting Commissioner within 9 months of the public meeting.
The National Nanotechnology Initiative (a US government R&D coordinating program) refers to nanotech as “the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications.” A nanometer is one billionth of a meter. A human hair is about 80,000 nanometers in width.
Materials made in the nanoscale size range can often have chemical or physical properties that are different from those of their larger counterparts. Such differences include altered magnetic properties, altered electrical or optical activity, increased structural integrity, and increased chemical and biological activity. Because of these properties, nanotech materials have great potential for use in many products. Also, because of some of their special properties, they may pose different safety issues than their larger counterparts.