Median approval times in 1996 were 15.4 months for drugs and 14.9 months for biologics, down from 16.5 months and 17.6 months, respectively, in 1995. Fifty-three of the drugs approved were new molecular entities. Eight of the licensed biological products were first-time entities. Also of note were five new HIV test kits. The claims that foods with soluble fiber from whole oats may reduce heart disease risk when eaten as part of a diet low in saturated fat and cholesterol is now allowed under an FDA final rule.
Foods covered by the action include rolled oats, oat bran, and whole-oat flour.
This conclusion is based on a scientific review showing a link between the soluble fiber in whole-oat foods and a reduction in coronary heart disease risk. To qualify for the claim, whole-oat foods must provide at least 0.75 grams of soluble fiber per serving. About 3 grams of soluble fiber is needed daily for an effect on cholesterol levels. FDA acknowledges that other sources of beta-glucan soluble fiber and other types of soluble fiber may have similar effects on cholesterol levels. But the agency is awaiting evidence before judging these effects.