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March 10, 2009

Media Inquiries:
Karen Riley, 301-796-4674
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FDA and Eight Academic and Research Institutions to Collaborate Under Nanotechnology Initiative
Overarching goal: developing an efficient pathway for safe and effective nanoengineered medical products

The U.S. Food and Drug Administration today unveiled a new collaboration initiative with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology.

Under a Memorandum of Understanding, the FDA/ANH Nanotechnology Initiative will work to expand knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that might mitigate the risks associated with nanoengineered products. All outcomes from this public-private partnership will be placed in the public domain for the benefit of all stakeholders

"FDA's Nanotechnology Initiative with the Alliance for NanoHealth is an effort to engage resources and technical expertise in this rapidly advancing field and is a clear example of leveraging science and scientists to advance the public good," said the FDA's Acting Commissioner, Frank M. Torti, M.D., M.P.H. "Nanotechnology holds great promise for the advancement of novel medical products."

Nanotechnology involves the creation and use of materials at the level of molecules and atoms and presents challenges and opportunities for the FDA's entire regulatory product jurisdiction, from food to medical devices to therapeutics.

The eight academic institutions include Baylor College of Medicine, the University of Texas' M.D. Anderson Cancer Center, Rice University, the University of Houston, the University of Texas Health Science Center at Houston, Texas A & M Health Science Center, the University of Texas Medical Branch at Galveston, and the Methodist Hospital Research Institute.

"We are delighted with this partnership between the FDA and the eight institutions that constitute the Alliance for NanoHealth," said Larry Kaiser, M.D., president, the University of Texas Health Science Center, on behalf of the ANH and its eight member institutions. "We see this agreement as an important step on the path to taking advantage of the enormous power of nanotechnology to improve the diagnosis and treatment of disease."

FDA's collaboration with the ANH is an example of the agency's Critical Path Initiative, launched in 2004 to work on next generation tools such as new assays, new biomarkers, better clinical trial designs and better endpoints and new manufacturing methods to encourage the development of efficient and effective FDA-regulated products.



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