Miller John
Stanford Law School, USA.
Columbia Sci Technol Law Rev. 2003;4:E5.
Nanotechnology, which involves investigating and manipulating matter at the atomic and molecular levels, may radically transform industry and society. Because nanotechnology could introduce whole new classes of materials and products, it could present an array of novel challenges to regulatory agencies. In this note, John Miller explores the regulatory challenges facing the Food and Drug Administration in regulating nanomedical products. First, the FDA will have trouble fitting the products into the agency's classification scheme. Second, it will be difficult for the FDA to maintain adequate scientific expertise in the field. He concludes that the FDA should consider implementing several reforms now to ensure that it is adequately prepared to regulate nanomedicine.
纳米技术涉及在原子和分子层面研究和操控物质，它可能会给工业和社会带来根本性变革。由于纳米技术能够引入全新类型的材料和产品，所以可能会给监管机构带来一系列新挑战。在本报告中，约翰·米勒探讨了美国食品药品监督管理局（FDA）在监管纳米医疗产品时所面临的监管挑战。首先，FDA很难将这些产品纳入该机构的分类体系。其次，FDA难以在该领域维持足够的科学专业知识。他得出结论称，FDA现在应考虑进行若干改革，以确保其有充分准备来监管纳米医学。
