送交者: Yush 于 2006-4-29, 22:02:34:
回答: NCI的消息比较客观.就是不知道NCI的phase2/3 trial 和FDA的新药试验是不是一回事. 由 PoohHunny2 于 2006-4-29, 16:25:23:
NCI报告有一段提到FDA新药试验，
说他那个膳食补充剂无需FDA核准，并且FDA也没有核准过
NCI报告
In the United States, dietary supplements are regulated as foods, not drugs. Therefore, premarket evaluation and approval by the Food and Drug Administration (FDA) are not required unless specific disease prevention or treatment claims are made. The FDA can, however, remove from the market dietary supplements that it deems unsafe. It should be noted that no formulation of Selected Vegetables/Sun’s Soup has been approved by the FDA for the treatment of cancer or any other medical condition.