FDA to hold nanotechnology public meeting

April 18, 2006 — /MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM)/ — COSTA MESA Calif. — The FDA will be holding a public meeting in fall 2006, designed to gather information about current developments in uses of nanotechnology materials in FDA regulated products.

Nanotechnology is described by the National Nanotechnology Initiative as the understanding and control of matter at dimensions of roughly 1-100 nanometers, where unique phenomena enable novel applications. Essentially, nanotechnology is a branch of science devoted to the design and production of extremely small matter.

Due to the small size and special properties of nanotechnology materials, they have great potential for use in a vast array of FDA-regulated products. These small materials often have physical or chemical properties that are different than those of their larger counterparts. Differences include altered magnetic properties, altered electrical or optical activity, increased structural integrity, and enhanced chemical and biological properties.

These differences have the potential to lead to scientific advances. For example, this technology could be used to create new drug formulations and routes of delivery to previously inaccessible sites in the body.

The FDA is holding this meeting to further understand nanotech developments and to hear:

— About the new types of nanotech products under development human and animal drugs, and human biologics and medical devices

— About any specific scientific issues related to developing these products

— Any other issues about which industry, academia and the public may wish to inform FDA concerning the use of nanotechn in FDA-regulated products

— If there are opportunities for the agency to address hurdles that may be inhibiting the use of nanotech in medical product development

While the agency is not accepting registrations at this time, it would appreciate receiving expressions of interest from those intending to attend or present at the meeting. This information will help FDA prepare and plan for this meeting. Information can be provided to Poppy Kendall at [email protected], or 301-827-3360.

Based on the level of response, FDA will obtain a venue and structure the meeting to accommodate the audience and range of topics discussed. Details about the venue, specific date, time, and registration will be provided in a Federal Register notice closer to the meeting. You may also look for updates at www.fda.gov/nanotechnology.

COMMENTS MAY BE SUBMITTED ELECTRONICALLY AT:

http://sacserv.com/tracking.jsp?linkid=32757&subid=3838834&campid=147829&type=0

or mailed to the FDA Div of Dockets Management (HFA), 5630 Fishers Ln Rm 1061, Rockville MD 20852. All comments should refer to Docket #2006N-0107.

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