FDA considerations regarding new hypolipidemic agents.
Food and Drug Administration policy being considered for new marketed hypolipidemic agents includes: long-term safety to be demonstrated in postmarketing studies; evidence of clinical effectiveness to be demonstrated within a specified time period. Effectiveness is to be judged by one or more of the following: reduction in xanthomata, reduction atherosclerotic plaque, reduction in morbidity of coronary artery disease or peripheral and cerebral atherosclerosis, and reduction in mortality. Randomized double blind trials are deemed necessary.
D000960:Hypolipidemic Agents / Q000592:standards*; D009316:National Institutes of Health (U.S.); D014481:United States; D014486:United States Food and Drug Administration
D000960:Hypolipidemic Agents