title: What we know and don't know about the bioeffects of nanoparticles: developing experimental approaches for safety assessment.
abstract: The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) regulates nano-based medical products and therefore is required to address the safety and biological effects of nano-scale materials used in these products. Both in vitro and in vivo toxicological research studies are being conducted at the FDA to help determine the risks versus benefits of these new products. This article will briefly summarize some of the initial research findings from FDA-CDRH studies using TiO(2), polystyrene, and silicon nanoparticles.
authors.affiliation: Center for Devices and Radiological Health, Food and Drug Administration, WO64-4078, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA. melvin.stratmeyer@fda.hhs.gov
authors.forename: Mel E
authors.initials: ME
authors.lastname: Stratmeyer
authors.forename: Peter L
authors.initials: PL
authors.lastname: Goering
authors.forename: Victoria M
authors.initials: VM
authors.lastname: Hitchins
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Umbreit
mesh_terms: D000818:Animals; D006801:Humans; D053758:Nanoparticles / Q000633:toxicity*; D012106:Research; D012449:Safety; D014116:Toxicology / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration