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Jill Wechsler is Pharmaceutical Technology's Washington Editor, firstname.lastname@example.org.
The US Food and Drug Administration seeks to understand nanotechnology better and exercise appropriate oversight over products that incorporate it.
Nanotechnology has many potential applications in the pharmaceutical industry, and is already being used in consumer products such as sunscreen. But some questions about nanotechnology's interaction with the body and effects on the environment remain unanswered. The US Food and Drug Administration seeks to understand nanotechnology better and exercise appropriate oversight over products that incorporate it.
To address scientific and regulatory issues raised by nanotechnological products, FDA is conducting research in several areas. One lead project will study the dermal penetration and characterization of nanoparticles in sunscreens. Many nanotechnology research projects involve FDA collaboration with other federal agencies, academia, international organizations, and industry. FDA cochairs the nanotechnology subcommittee of the Interagency Oncology Task Force with the National Cancer Institute (NCI) at the National Institutes of Health (NIH). A collaboration with the NIH NanoHealth Enterprise aims to share data relating to nanotechnology product development, including research about failed product candidates and biological interactions of certain nanoscale materials.
An important research partner for FDA is the National Institute of Standards and Technology (NIST), which is engaged in several projects involving the selection of standard reference nanomaterials. FDA, NCI, and NIST jointly support the Nanotechnology Characterization Laboratory (NCL), which works with academia and industry to translate "nano" into the clinical realm. NCL is characterizing nanoparticles, conducting structure activity relationship studies and facilitating regulatory review of nanotechnology constructs. A new project is to evaluate the size, purity, and composition of new imaging agents from General Electric to determine toxicology. FDA also cochairs the federal government's Nanotechnology Environmental Health Implications working group and is active in the Nanotechnology Policy Coordination Group, which looks at policy issues across all government agencies.
International harmonization and coordination is of growing importance as nanotechnology develops globally. FDA helps track international interactions in this area as a member of the federal government's Global Issues in Nanotechnology task force. The agency is actively involved in testing 14 nanomaterials for 59 endpoints with members of the Organization of Economic Cooperation and Development. Discussions related to nanotechnology are taking place under the International Cooperation on Cosmetic Regulation, the World Health Organization, and the United Nations's Food and Agriculture Organization. For medical devices, FDA officials discuss these issues through the Global Harmonization Task Force. And bilateral discussions are taking place with major trading partners to review risk-assessment methods, data needs, and reporting standards.
For more on this topic, see "Nanotechnology Challenges FDA and Manufacturers".