Kahan J S, Gibbs J N
Appl Biochem Biotechnol. 1985 Dec;11(6):507-16. doi: 10.1007/BF02798644.
The Food and Drug Administration (FDA) is facing a flurry of new products coming to market over the next few years that will be based on biotechnology. The agency will have to deal with state-of-the-art drugs and devices utilizing biotechnology as the developmental base. Also, many universities and companies are exploring the potential uses of biotechnology in developing new foods and food additives. This article will examine how the FDA is presently regulating medical device, and food and food additive biotechnology and the challenges confronting the agency in these areas in the future.
美国食品药品监督管理局（FDA）正面临着未来几年即将上市的一系列基于生物技术的新产品。该机构将不得不应对以生物技术为研发基础的前沿药品和器械。此外，许多大学和公司正在探索生物技术在开发新食品和食品添加剂方面的潜在用途。本文将探讨FDA目前如何监管医疗器械、食品和食品添加剂生物技术，以及该机构未来在这些领域面临的挑战。
