Nanotechnology And The FDA: Size Matters!

Main Category: Medical Devices / Diagnostics
Also Included In: Conferences;  Pharmacy / Pharmacist;  Regulatory Affairs / Drug Approvals
Article Date: 06 Sep 2008 - 1:00 PDT

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The Food & Drug Administration (FDA) issued in July 2007 its Nanotechnology Task Force Report. This report acknowledged that nanoscale materials potentially could be used in most product types regulated by the agency and that those materials present challenges complicated by the fact that properties relevant to product safety and effectiveness may change as size varies within the nanoscale.

Anticipating the potential for rapid commercialization in the field, the FDA report recommended consideration of agency guidance that would clarify what information industry needs to provide FDA about nanoproducts, and also when the use of nanoscale materials may change the regulatory status of products. On September 8, FDA is holding a public meeting to gather comments and data to assist the agency in the development of that guidance.

The meeting agenda will include product-specific presentations and discussion on:

1. Medical devices;
   
   
2. Prescription drugs, including over-the-counter (OTC) drugs like sunscreens;
   
   
3. Food and color additives, including food contact substances;
   
   
4. Dietary supplements; and
   
   
5. Cosmetics.

Several leading experts and authors of reports on nanotechnology oversight published by the Project on Emerging Nanotechnologies (http://www.nanotechproject.org/) will submit and present testimony before this landmark public meeting addressing key policy issues concerning FDA's current and future regulation of nanoscale materials.

What:

Food & Drug Administration public meeting to assist the agency in implementing the recommendations of the FDA Nanotechnology Task Force Report (http://www.fda.gov/nanotechnology2008/).

When:

Monday, September 8, 2008, 8:30 AM - 5:00 PM

Who:

Dr. Andrew Maynard, Chief Science Advisor, Project on Emerging Nanotechnologies (presentation: cosmetics)

William B. Schultz, former FDA official and attorney, Zuckerman Spaeder, LLP (presentation: dietary supplements)

Michael R. Taylor, former FDA official and Research Professor of Health Policy at the School of Public Health, George Washington University (presentation: food and food packaging)

Where:

University Systems of Maryland Shady Grove Center/Universities, 9630 Gudelsky Dr., Rockville, MD 20850 (http://www.shadygrove.umd.edu/conference). There is parking near the building.

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About Nanotechnology

Nanotechnology is the ability to measure, see, manipulate and manufacture things usually between one and 100 nanometers. A nanometer is one billionth of a meter; a human hair is roughly 100,000 nanometers wide. In 2007, the global market for nanotechnology-based products totaled $147 billion. Lux Research projects that figure will grow to $3.1 trillion by 2015.

The Project on Emerging Nanotechnologies was launched in 2005 by the Wilson Center and The Pew Charitable Trusts. It is an initiative dedicated to helping business, governments, and the public anticipate and manage the possible health and environmental implications of nanotechnology.

Source: Colin Finan
Project on Emerging Nanotechnologies

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