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2013 Global Summit on Regulatory Science (GSRS13)
Dates: September 11-12, 2013
Location: Little Rock, Arkansas
Research at NCTR
Nanotechnology, the manipulation of material at dimensions between 1 and 100 nm (0.001 to 0.1 micrometer), is a challenging scientific area where specific tools are needed to characterize and detect the nanoscale materials. Many conventional detection methods do not allow scientists to analyze or confirm the size and properties of these materials in FDA-regulated products. Recent advances have allowed scientists the ability to visualize, manipulate, and control matter of this size. The FDA has already reviewed and approved some nanotechnology-based products, and expects a significant increase in the use of nanoscale materials in drugs, devices, biologics, cosmetics, and food. Through the NCTR/ORA Nanotechnology Core Facility, NCTR and ARL are working together to translate the methodologies to detect nanoscale materials in toxicological studies to the detection of nanoscale materials in biological samples of FDA-regulated products.
The newly created NCTR/ORA Nanotechnology Core Facility supports nanotechnology toxicity studies, develops analytical tools to quantify nanomaterials in complex matrices, and develops procedures for characterizing namomaterials in FDA-regulated products.
The facility is located at the FDA’s Jefferson Arkansas Laboratories with a goal to meet the needs of the National Center for Toxicological Research (NCTR), an FDA research center that conducts toxicological studies to understand the toxicity and biological impact of nanoscale materials in animal systems, and the Office of Regulatory Affairs/Arkansas Regional Laboratory (ORA/ARL), a regulatory FDA Center that monitors nanoscale materials in FDA-regulated products.
Nanotechnology research projects at NCTR include:
- The Development of Novel Nanotube-Based Technologies That Benefit Public Health, Protect the Public, Produce High-Efficiency Separations and Filtration, and Improve Energetic Material Therapeutics (E0720501)
- Skin Penetration, Phototoxicity, and Photocarcinogenicity of Nanoscale Oxides of Titanium and Zinc. QUANTUM DOT (E0215611)
- Tumorigenicity of Photoactive Nanoscale Titanium Dioxide in Tg.AC Transgenic Mice (E0215801)
- Neurotoxicity Assessment of Manganese Nanoparticles in PC 12 Cells and in Mice (E0725701)
- Neurotoxicity Assessment of Silver (Ag) Nanoparticles in PC-12 Cells and in Rats (E0728201)
- Use of Electron Spin Resonance Spectroscopy to Characterize the Interactions Between Nanoscale Materials and Model Biological Systems (E0730601)