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FDA Nanotechnology Task Force Report Outlines Scientific, Regulatory Challenges
Fact Sheet

Nanotechnology is changing the way that many FDA-regulated products will be made.  To further its mission of promoting and protecting the public health, FDA will work to clarify what information will be needed in its efforts to oversee products that contain nanoscale materials –those created at sizes as small as 1/100,000th of a human hair.

The Food and Drug Administration’s Nanotechnology Task Force report released in July 2007 addresses the science and regulatory needs to regulate drugs, medical devices and other products built on the nanoscale.   

• Nanotechnology may provide new drugs that are able to reach specific areas of the body more effectively and at safer doses.
• “Nanomedicine” includes development of tiny sensors that detect disease markers in the body far earlier than existing diagnostic methods, and incredibly small pumps capable of delivering medications precisely to the cells and tissues that need them.
• Other examples of nano-products in development include disease imaging tools and food packaging that further extends shelf life.

FDA Commissioner, Dr. Andrew C. von Eschenbach says "Nanotechnology holds enormous potential for use in a vast array of products.  Recognizing the emerging nature of this technology and its potential for rapid development, this report fosters the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials.”

The Task Force reported that the potential use of nanoscale materials includes most product types regulated by FDA and that those materials present regulatory challenges similar to other emerging technologies. The Task Force recognizes, however, that product safety and effectiveness can change as size goes up or down within the nanoscale, adding additional complexity to the product review.

The emerging and uncertain nature of nanotechnology and the potential for rapid development of FDA-regulated products using this particular technology make it all the more important that in regulating nanotechnology FDA follow its transparent, consistent, and predictable process. The report recommends:

• Consideration of guidance that would clarify what information manufacturers should give FDA about products, and also when the use of nanoscale materials may change the regulatory status of particular products.
• That manufacturers contact the FDA early in the product development process. In addition, the report recommends that the agency should assess data needs for regulated nanotechnology products, including biological effects and interactions of nano-particles.
• That FDA develop in-house expertise and ensure the consideration of new information on nanotechnology as it becomes available. FDA also should evaluate current testing approaches to assess the safety, effectiveness, and quality of nanoscale materials. 

FDA and 22 other federal agencies are part of the National Nanotechnology Initiative, a federal research and development program established to coordinate the multi-agency efforts in nanoscale science, engineering, and technology.

For more information:

National Nanotechnology Initiative
http://www.nano.gov/

FDA Consumer Information:
http://www.fda.gov/consumer/updates/nanotech072507.html

Nanotechnology Home Page

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