Kelsey F O
Teratology. 1982 Apr;25(2):193-9. doi: 10.1002/tera.1420250208.
The Food and Drug Administration is a scientific regulatory agency whose consumer protection activities cover a wide range of products including foods and additives, and pesticide residues on foods; drugs; cosmetics; medical devices; and radiation-emitting electronic products. Amongst its concerns is the possible teratogen effects of regulated products to which the pregnant woman is exposed. The policies and programs of the agency directed toward reducing such risks to the unborn are reviewed. These measures include guidelines for animal reproduction studies and for clinical trials involving women to childbearing potential; labeling of products to disclose known or possible harm to the fetus or embryo; surveillance procedures designed to detect previously unsuspected adverse effects of marketed products; research activities designed to develop better understanding of developmental toxicology and improved techniques for detecting embryocidal and embryotoxic effects; and educational efforts directed both to professionals and the public regarding hazards to the unborn of agency-regulated products.
美国食品药品监督管理局是一个科学监管机构，其消费者保护活动涵盖广泛的产品，包括食品和添加剂、食品上的农药残留、药品、化妆品、医疗器械以及发射辐射的电子产品。该机构关注的问题之一是孕妇接触到的受监管产品可能产生的致畸作用。本文回顾了该机构旨在降低对未出生胎儿此类风险的政策和计划。这些措施包括动物生殖研究指南以及涉及有生育潜力女性的临床试验指南；产品标签，以披露已知或可能对胎儿或胚胎造成的危害；监测程序，旨在检测市售产品先前未被怀疑的不良反应；研究活动，旨在更好地理解发育毒理学并改进检测胚胎致死和胚胎毒性作用的技术；以及针对专业人员和公众开展的关于该机构监管产品对未出生胎儿危害的教育工作。
