Beyond biotechnology: FDA regulation of nanomedicine.
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.
Miller
John
J
Stanford Law School, USA.
D016503:Drug Delivery Systems / Q000379:methods; D015316:Genetic Therapy; D033161:Government Regulation; D008511:Medicine; D036103:Nanotechnology / Q000331:legislation & jurisprudence*; D004364:Pharmaceutical Preparations; D012106:Research; D012371:Robotics; D012922:Social Change; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations